Respironics California Inc Recalls
Showing 1-19 of 19 recalls
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.
The firm, Philips, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2017 to its customers. The Customers letter inform them that Respironics California is recalling the Philips V60 Noninvasive Ventilators manufactured before 15 September 2015; that the recall is for all V60s with date of manufacture before 15 September 2015 and not for V60 Ventilators manufactured on or after 15 September 2015; of the recall reason, risk to health, how to identify devices subject to recall, and actions to be taken the customers. The customers were also instructed to complete and return the RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: recall.response@philips.com or fax to: 1-877-499-7223 or mail to: Philips Healthtech, Mailstop# 4202, 3000 Minuteman Road, Andover, MA 01810-1032. On 5/9/17, Respironics has revised customer notification letter and began sending it out to their customers. The update includes the following actions to be taken: "appropriately trained personnel may continue using the V60" and "ensure an alternative form of ventilation device is available at all times, including intra-hospital transport (e.g. manual ventilation bag)." Philips will contact each consignee to schedule an appointment for this recall. Philip Engineers will remediate any affected V60 ventilators at the site. If you have any questions, please contact the Head of Q & R at 760-918-1067 or donald.sherratt@philips.com.
Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709
The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.
Philips sent an Urgent- Medical Device Letter dated February 1, 2017, to all affected customers. It will be sent the week of February 6, 2017, to inform customers that Respironics is voluntarily recalling all Philips V60 Non Invasive Ventilators (NIV) that have Version 2.20 Software installed. Customers are informed that the V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease. An audible high-priority alarm will sound continuously for at least 2 minutes when the V60 shuts down for any Vent Inop condition and is operating on battery power. If the V60 is connected to AC power (mains supply), the alarm will continue to sound until an operator intervenes. If the V60 is connected to a remote alarm system, the alarm system will be activated until action is taken by the operator. Error Code 100E only exists in V60 Version 2.20 software. Therefore, V60s running Version 2.10 software are not subject to this particular Vent Inop condition. E-mail back the complete form attached to the rear of this recall notification to recall. response @ Philips. com or Fax to 1-877 499-7223. For further questions please call (760) 918-7300.
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
Philips Healthcare sent an Urgent - Field Safety Notice dated September 17, 2014, to all customers who purchased the Esprit V1000 and V200 Ventilators to inform them that Respironics is recalling Esprit V1000 and V200 Ventilators installed with 3rd Generation Power Supplies and also 3rd Generation Power Supply Repair Part Kits. The letter identifies the affected devices, informs the customers of the problems, hazard involved, and the actions to be taken. Customers were reminded to be advised of the warnings provided. A Philips Respironics representative will contact customers to schedule a no-cost replacement for further information or support. Customers with questions were instructed to contact Philips Healthcare at 1-800-722-9377. For questions regarding this recall call 760-918-7300.
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.
Philips Healthcare sent an Urgent - Field Safety Notice to all affected consignees to inform them that Respironics is recalling the Esprit V1000 and Esprit/V200 Conversion ventilators because if the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted. A high urgency audible alarm will sound alerting medical personnel of the loss of power. In the absence of AC power, failure of battery power will cause loss of ventilator support, which may result in hypercarbia or hypoxemia. The potential issue affects ventilators manufactured prior to 12/31/04 due to design of the fan/shroud assembly. Esprit V1000 and Esprit/V200 Conversion Ventilators manufactured after that affected date are not affected. Customers with concerns were instructed to contact a Philips Respironics representative at (800) 722-9377. For questions regarding this recall call 760-918-7300.
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. Th
Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
The firm, Philips Healthcare, sent a "MEDICAL DEVICE CORRECTION" letter dated June 3, 2013 to all customers who received the V60 Ventilators. The letter describes the product, problem identified and the actions to be taken. The customers were informed that the V60 ventilator may continue to be used in accordance with its directions for use, pending the completion of the update. In addition, the customers were instructed to refer to their manual for additional information on warnings. A Philips Field Service Engineer, Approved Sevice Provider or Distributor will be contacting the customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013. If you need any further information or support concerning this issue, contact your local Philips Respironics representative at (800) 722-9377.
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.
A Medical Device Field Correction letter dated 10/26/2007 was sent to all customers who received the Esprit Ventilator. The recall letter informed the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact Respironics' Customer Service Dept. at (800) 345-6443, select Option#5, then select Option #4.
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 2
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
Respironics California a division of Philips Healthcare sent a Medical Device Correction letter dated July 31, 2012 to all affected customers. The letter identified the affected product, problem identified and actions to be taken. The letter states that a Phillips Respironics Field Service Engineer or distributor will be contacting customers to schedule a no-cost replacement of the blower motor assembly on all affected V60 ventilators. For information or support concerning the recall issue, contact Philips Respironics at (800) 722-9377.
Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
The recall was initiated because through routine product monitoring Respironics discovered that under certain conditions, when operating on AC line power, a portion of the current from the External Battery charger is erroneously diverted to the ventilator. When this occurs, the External Battery charger may not transition correctly. Prolonged operation in this condition results in overcharging and
Respironics California, Inc. issued an "Urgent - Medical Device Field Correction" notice dated April 22, 2009. Customers were informed of the affected device including corrective actions taken by the firm. A Respironics representative will contact customers to schedule service of the device. Further questions can be addressed by contacting Respironics US Customer Service at 1-800-345-6443.
Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator.
On January 25, 2008, letters were sent to all existing Esprit distributors in > 200 volt countries. This letter notified customers of the pending field action, the reason for the action and included a set of instructions that end users need to follow in order to be able to continue using their Esprit pending the installation of replacement parts. The letter also stated that as soon as replacement parts are available, customers will be provided with a serial number list of their affected units. Respironics will provide replacement parts at no cost and instructions to upgrade the Esprit Ventilators and FRUs in each distributors respective region. Contact Respironics California, Inc. at 1-760-918-7328 for assistance.
RESPIRONICS V60 VENTILATOR
The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation fo
The recall notification was initiated October 26, 2009 with the firm mailing a Urgent Medical Device Field Correction letter to the affected customers. The letter informed the customers of the reason for the notice and how Respironics Field Service Technicians were going to correct this issue. The letter also gave the customers instructions to follow pending the completion of the field inspection/replacement. For questions or additional information contact Respironics US Customer Service at 1.800.345.6443, Option #5 then Option #1.
Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage.
Phililps Healthcare issued an Urgent Medical Device Field Correction letter dated July 2, 2010 concerning the RespironicsV60 Ventilator issue. Customers will be contacted by US Field Service Technicians and international distributors to schedule and perform inspections and replacement of the affected component. The unit may continue to be used pending completion of the field inspection. Customers may contact Respironics US Customer Service about this action at 1 800 345 6443, option #5, then option #1.
Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settin
Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau
Respironics California, Inc. issued an "Attention - Medical Device Field Correction" letter addressed to the Customer/Distributor dated September 22, 2008. The letter informed consignees of the affected device and instructions for removal, device replacement and return of the Business Response form by fax to 1-760-918-0169. Further question may be addressed to Respironics US Customer Service at 1-9800-345-6443 extension 5 or Respironics International Customer Service at 1-724-387-4000.
Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246
This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases in which a fan also failed, have shown signs of fire damage.
The field action will be conducted through consignees (distributors) in the affected countries. The distributors were notified of the field action by Federal Express au on August 8th, 2006. The distributors have been informed that Respironics will provide replacement circuit boards at no cost and will be instructed to upgrade the ventilator power supplies in their region. Instructions have been provided to the distributors and users on how to evaluate the ventilator to be able to continue to use it pending the completion of the upgrades. The distributors will document the replacement of the affected component by signing and dating the activity on the Ventilator Field Action Log (reference sample on Appendix IV). The serial number of the power supply destroyed will also be recorded on the log.
The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings a
During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.
On November 18, 2005 all affected customers received a personal phone call from Respironics explaining the recall situation in detail. On November 21, 2005, an advisory notice was sent to customers via fax, email, or mail, instructing customers to only use your PLV Continuum Ventilator in the 'Face Foward' orientation. The firm will contact customers with further information shortly to assure that this situation is positively resolved. Customers were instructed to Only use the PL V Continuum Ventilator in the 'Face Forward' orientation. In the event that a customer requires the application of the PLV Continuum Ventilator in the Face Up Orientation, Respironics will provide the customer, at no charge, with a rental PLV-l00, PLV-IO2b or PLV-I02 Ventilator for the customer to use until their PLV Continuum Ventilator is upgraded. If additional information is needed the customer was instructed to contact Respironics'' Customer Service at 800 345-6443.
Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The PL VC I user interface has a membrane keypad with indicator Light Emitting Diodes for the selection and acceptance of pati
Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs.
Notification letters were mailed to customers on March 20, 2006 notifying them of this action. Customers were instructed to quarantine all PLV Continuum Ventilators in their possession and not to place patients on them. Respironics Customers Service will contact customers to arrange for the return of all PLV Continuum Ventilators. Customers were instructed to safely plan and transition patients in their care from the PLV Continum Ventilator onto to other comparable patient support devices. If customers did not have a suitable ventilator to use for their patients, Respironics will loan them a PLV 100, 102 or 102b Ventilator with no charge. If patient support goes beyond the capabilities of the PLV 100, 102, or 102b Ventilator is required, Respironics will make arrangements to loan the customer with a suitable substitute rental ventilator at no charge. The field action will involve the upgrade of all affected devices with a new flow valve assembly. All US and International units are being recalled to the factory in Carlsbad, California. The rework will be conducted on-site.
Esprit Ventilator
Flow sensors would exhibit drift.
Oxygen flow sensors were replaced in all ventilators by service technicians in the USA. Parts were given to foreign consignees. Recall is complete.
Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
ESPRIT VENTILATOR, Model V1000
Material hardness on original design check valve may cause premature failure.
Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.
Esprit Ventilator.
Valves may stick in the closed position due to manufacturing error.
Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.