2010 Product Recalls
1,800 recalls issued in 2010.
Showing 1–20 of 1,800 recalls
DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.
Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.
Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.
Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.
Philips Medical Systems issued URGENT-Device Correction letters dated January 27, 2009 to consignees describing the issue with the Easy Diagnost Eleva GXR RF systems. The consignees were informed of the potential for incorrect diagnosis or treatment if an incorrect image is used for diagnosis. Consignees should contact the Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FC0 70600030" with any communication.
John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.
GF Health Products (Graham Field) notified consignees by certified US Mail on/about 09/14/2009. The distribution to the dealers includes the announcement of the recall to the dealer the letter to send to the end users and a Proof of Compliance card for the dealer to submit to Graham Field following completion of the recall instructions. Graham-Field instructed the dealers to return any impacted products on site, as well as any delivered by end-users, customers or other impacted third parties. Dealer will be compensated for executing the recall. Graham Field does not have direct access to end user names; however it plans to reach end-users by financially supporting a mailing from dealers to their individual customers notifying them of this recall. A follow up 60 day certified mailing will be performed for non-responders. The dealers will receive financial support for this second mailing. A secure third company will be contracted to hold for destruction all products affected by this recall. The method of destruction will be to cut the products into pieces, make them not usable. The FDA will be notified prior to the destruction of product and detailed logs and records will be maintained. Periodic effectiveness status report will be maintained for this recall.
PrecisePLAN 2.10 Treatment Planning System
Error in dose rates which were calculated at exactly twice the expected values.
As described in a prior related submission, Phase I - "Important Notice A285, Scrolling Selected Frame Dose Calculator Error" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken. Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200.
BODY CONTROL MODULE
IF AN ELECTRICAL SHORT DEVELOPS, AN OVERHEATING CONDITION MAY OCCUR WHICH CAN RESULT IN AN UNATTENDED VEHICLE FIRE.
DEALER WILL REPLACE THE BODY CONTROL MODULE IF NECESSARY FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 11, 2011. OWNERS MAY CONTACT FORD AT 1-866-436-7332.
FRONT DOOR WIRING
IN THE EVENT OF A CRASH, THE SIDE AIRBAG MAY NOT DEPLOY, REDUCING THE PROTECTION INTENDED FOR THE OCCUPANT AND INCREASING THE RISK OF INJURIES.
CHRYSLER WILL NOTIFY OWNERS AND REPLACE THE LEFT AND RIGHT DOOR WIRING HARNESSES FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 18, 2011. OWNERS MAY CONTACT CHRYSLER AT 1-800-853-1403.
TIE ROD ENDS
LOSS OF STEERING CONTROL OF THE VEHICLE COULD INCREASE THE RISK OF A CRASH.
CHRYSLER WILL NOTIFY OWNERS AND REPLACE THE LEFT OUTER TIE ROD FREE OF CHARGE. THE SAFETY RECALL BEGAN ON MARCH 7, 2011. OWNERS MAY CONTACT CHRYSLER AT 1-800-853-1403.
REAR AXLE
A FAILURE OF THE BEARING COULD CAUSE THE VEHICLE TO STALL INCREASING THE RISK OF A CRASH.
CHRYSLER WILL NOTIFY OWNERS AND WILL INSTALL AN OIL PORT INSERT INTO THE REAR AXLE FREE OF CHARGE. THE SAFETY RECALL BEGAN ON APRIL 4, 2011. OWNERS MAY CONTACT CHRYSLER AT 1-800-853-1403.
A-PILLAR STRUCTURE/FMVSS 201
IN THE EVENT OF A VEHICLE CRASH, THE VEHICLES MAY NOT PROVIDE THE PROTECTION REQUIRED BY THE STANDARD IF AN OCCUPANT STRIKES THE A-PILLAR TRIM.
MERCEDES-BENZ WILL CHECK TO SEE IF THE CORRECT TRIM COVER WAS INSTALLED AND, IF NOT, REPLACE THAT TRIM COVER WITH THE CORRECT ONE. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING FEBRUARY 2011. OWNERS MAY CONTACT MERCEDES-BENZ AT 843-695-5000.
KENWORTH/HOOD STRUT SAFETY LATCH
FAILURE OF THE SAFETY LATCH FEATURE MAY CAUSE THE HOOD TO UNEXPECTEDLY CLOSE WHILE OPEN, INCREASING THE RISK OF PERSONAL INJURY AND/OR VEHICLE DAMAGE.
DEALERS WILL REPLACE THE DUAL MAGNETS WITH A SINGLE MAGNET ON THE SAFETY LATCH. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 28, 2011. OWNERS MAY CONTACT KENWORTH AT 1-425-828-5440.
Honda snowblowers Recalled for Fire Hazard
The fuel tank joint and O-ring located on the underside of the fuel tank can seep or drip fuel over time, posing a fire hazard.
Consumers should immediately stop using the recalled snowblowers and contact any Honda Power Equipment dealer to arrange for a free fuel tank joint and O-ring replacement. Registered owners of the recalled snowblowers will be mailed a notice.
AIRBAG CIRCUIT/CLOCK SPRING WIRING CONNECTOR
IN THE EVENT OF A CRASH, THE DRIVER'S FRONTAL AIRBAG MAY NOT DEPLOY AS INTENDED OR AT ALL, AND THEREFORE WILL NOT BE ABLE TO PROPERLY PROTECT THE DRIVER, INCREASING THE RISK OF INJURIES.
ALPS ELECTRIC IS NOT CONDUCTING A RECALL CAMPAIGN. VOLVO CARS AND JAGUAR LAND ROVER ARE EACH CONDUCTING A RECALL CAMPAIGN ON THEIR RESPECTIVE VEHICLES ON WHICH THE DEFECTIVE EQUIPMENT WAS INSTALLED. VOLVO AND JAGUAR LAND ROVER WILL NOTIFY THEIR OWNERS AND DEALERS WILL PROVIDE A REMEDY FREE OF CHARGE. FOR MORE INFORMATION PLEASE SEE VOLVO'S RECALL CAMPAIGN 10V-489 OR JAGUAR LAND ROVER'S RECALL CAMPAIGN 10V-581.
PLUG IN REMOTE CONTROL RECEIVER FOR FIREPLACE
AN OVERHEATED RECEIVER COULD CAUSE A FIRE.
PETERSON IS WORKING WITH DIMPLEX TO IDENTIFY AND NOTIFY ANY AFFECTED OWNERS. DIMPLEX WILL PROVIDE OWNERS A FREE REPLACEMENT PLUG-IN REMOTE CONTROL KIT. THE SAFETY RECALL BEGAN ON FEBRUARY 15, 2011. OWNERS MAY CONTACT DIMPLEX NORTH AMERICA CUSTOMER SERVICE AT 1-888-346-7539 PETERSON AT 1-785-282-6825.
TRANS/AIR TA-73 EVAPORATOR/OVERHEATS
THIS WOULD CAUSE THE RESISTOR TEMPERATURE TO RISE TO A POINT WHERE IT WILL MELT AND POSSIBLY IGNITE THE PLASTIC BLOWER HOUSING TO WHICH IT IS MOUNTED. THE OVERHEATING CAN RESULT IN A FIRE.
COACH AND EQUIPMENT IN COOPERATION WITH TRANS AIR WILL INSTALL A THERMAL SHUTDOWN DEVICE IN SERIES WITH THE SPEED RESISTORS. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DECEMBER 29, 2010. OWNERS MAY CONTACT TRANS AIR WARRANTY AND SERVICE CENTER AT 1-800-673-2446.
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
Elekta, Inc. issued an "Important Notice" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided. For further information, contact Elekta, Inc. at 1-770-300-9725.
Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use.
In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.
Mandatory Field Change Order (FCO) 528 053 "Check for zinc plated Precise Table 'Z' mechanism fixation bolts", dated 1/11/2007 was distributed to all affected customers. The Change Order identified the product, stated the reason for the FCO, and the procedure to check and resolve the problem identified.
Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.
Cutera sent Certified letters sent to all consignees on May 8, 2010. The letter identified the product, the problem, and the action the consignees should take. Consigness were instructed to immediately stop using the handpiece and complete the attached Recall Tracker Form. A second letter was sent to customers who received a replacement handpiecce but did not return the affected devices. All affected products were to be exchanged for new or reworked devices. For questions contact customer service at (888) 428-8372, ext 5561.
Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.
Elekta, Inc. sent an Important Notice A343 dated October 14, 2010 to all affected consignees. The Notice identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed constantly monitor the patient before and during the treatment. Check the patient's position after every patient movement (e.g. coughing). Advise all appropriate personnel of the content of the notice place a copy of the Notice In the Important Notice Section of the HeadFix User Manual P10103-108. For questions regarding this recall service.schwabmuenchen@elekta.com
Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body.
The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
On 05/12/2009, Philips began sending out the URGENT-Field Safety Notice MR Accessory Cart to their consignees. The letter identified the affected product and stated that the drawer rails were made from magnetic material and were not according specification. The hazards involved were also provided along with how to identify the affected product. The firm issued the FCO 78100296 and the firm's Field Service Engineer replaced the magnetic rails with the non-magnetic rails at the consignee's site. The consignees can contact contact the Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and reference FCO 78100296 with any communication.