2010 Product Recalls

Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold" mechanism. The purpose of which is to prevent two vapourisers being turned on simultaneously.. The product is labeled in part: "BleaseSirius Anesthesia System...SPACELABS Healthcare...Blease Medical

Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems.

Spacelabs Healthcare issued an URGENT MEDICAL DEVICE CORRECTION letter dated June 25, 2009 to the two consignees in the US. Spacelabs Healthcare UK notified consignees outside the US. The consignees were advised to brief their staff about the issue and test the Anesthesia Systems in advance of a procedure. If there is an issue with turning on a vaporizer in the left hand position, simply move the vaporizer to the right hand position. The firm contacted their consignees for a schedule to replace the flowmeter mouldings. The US consignees can contact Spacelabs Healthcare Representatives at 425-657-7200 ext. 5089 about this recall. Foreign consignees can contact Spoacelabs at 44 1494 784422.

PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments.

The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Discontinue use of this method of creating a patient case until FCO 772 00 540 064, (entitled "Update for Patient creation method using DICOM CT with Body Outline"), is received from Elekta to update th

Important Notice A297, "PrecisePLAN release 2.15 with DICOM CT with Body Outline" method of patient creation (dated May 8, 2007) was distributed to all customers. An additional Field Change Order 540 073, dated September 30, 2008 was distributed to customers. Important Notice A316 "Cancellation of Important Notice for PrecisePLAN" was issued. The Important Notice instructed affected users to dispose of Important Notice A297 and replace it with Important Notice A316. If you have any questions regarding the notification, please contact your local Elekta representative directly.

Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.

Radiation unit doors could close too fast on emergency exit.

Field Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product. For further information, contact Elekta, Inc. at 1-770-300-9725.

Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.

There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.

Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.

Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.

Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.

Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined t

The precision of the calculation used to create the fused study in LGP 8.0 is too low and should not be used until the system is upgraded to LGP 8.2.

Phase 1 - Important Notice and Technical Note #200 058 - "Accuracy problems in Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field Change Order #200 058, "Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2. For further question, do not hesitate to contact your Elekta support respresentative at

REFRIGERATORS/POSSIBLE FIRE/NORCOLD

THE SENSING ALGORITHM OR THERMAL SWITCH INSTALLED TO SHUT OFF POWER TO THE REFRIGERATOR WHEN HIGH TEMPERATURES ARE DETECTED DUE TO A POSSIBLE HYDROGEN GAS LEAK MAY NOT SHUT OFF IN SUFFICIENT TIME TO PREVENT A FIRE.

STARCRAFT IS WORKING WITH NORCOLD TO IDENTIFY AND NOTIFY ANY AFFECTED OWNERS. OWNERS WILL BE INSTRUCTED TO CONTACT NORCOLD DEALERS TO RECEIVE THE REMEDY FREE OF CHARGE. PLEASE SEE NORCOLD'S DEFECT REPORT 10E-049 FOR ADDITIONAL INFORMATION. THE RECALL BEGAN ON JANUARY 31, 2011. OWNERS MAY CONTACT NORCOLD AT 1-800-767-9101.

REFRIGERATORS/POSSIBLE FIRE/NORCOLD

ENTEGRA IS WORKING WITH NORCOLD TO IDENTIFY AND NOTIFY ANY AFFECTED OWNERS. OWNERS WILL BE INSTRUCTED TO CONTACT NORCOLD DEALERS TO RECEIVE THE REMEDY FREE OF CHARGE. PLEASE SEE NORCOLD'S DEFECT REPORT 10E-049 FOR ADDITIONAL INFORMATION. THE RECALL BEGAN ON JANUARY 25, 2011. OWNERS MAY CONTACT NORCOLD AT 1-800-767-9101.

REFRIGERATORS/POSSIBLE FIRE/NORCOLD

JAYCO IS WORKING WITH NORCOLD TO IDENTIFY AND NOTIFY ANY AFFECTED OWNERS. OWNERS WILL BE INSTRUCTED TO CONTACT NORCOLD DEALERS TO RECEIVE THE REMEDY FREE OF CHARGE. PLEASE SEE NORCOLD'S DEFECT REPORT 10E-049 FOR ADDITIONAL INFORMATION. THE RECALL BEGAN ON JANUARY 31, 2011. OWNERS MAY CONTACT NORCOLD AT 1-800-767-9101.

WHEEL/MIS-ALIGNED WELDS/TREDIT

THERE COULD BE A POTENTIAL WHEEL FAILURE AND WHEEL LOSS INCREASING THE RISK OF A CRASH, OR PERSONAL INJURY.

DEALERS WILL INSPECT THE WHEELS ON THE SUSPECT VEHICLES AND REPAIR THE TRAILERS FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 14, 2011. OWNERS MAY CONTACT FOREST RIVER AT 574-389-4600.

INTERMEDIATE STEERING COLUMN/TRW

MISLOCATED WELDS MAY RESULT IN TORSIONAL AND AXIAL STRENGTH FALLING BELOW ACCEPTABLE LEVELS. THIS CONDITION COULD RESULT IN SEPARATION OF THE STEERING COLUMN, LOSS OF STEERING CONTROL AND A VEHICLE CRASH WITHOUT WARNING.

DAIMLER TRUCKS/FREIGHTLINER WILL HANDLE THE REMEDY AND QUARTERLY REPORTS FOR THIS CAMPAIGN. PLEASE SEE FREIGHTLINER'S DEFECT REPORT (10V-322). FREIGHTLINER WILL NOTIFY OWNERS AND THE BUSES WILL BE REPAIRED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON DECEMBER 23, 2010. OWNERS MAY CONTACT DAIMLER TRUCKS/FREIGHTLINER AT 1-800-547-0712.

LP GAS TANK

IN THE EVENT OF A FIRE, THERE IS A POTENTIAL FOR PROPERTY DAMAGE, PERSONAL INJURY OR DEATH.

DEALERS WILL RELOCATE THE HEAT SHIELD TO THE PROPER LOCATION ON THE CHASSIS TO PROTECT THE LP TANK. THIS SERVICE WILL BE PERFORMED FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 3, 2011. OWNERS MAY CONTACT THOR MOTOR COACH AT 877-500-1020.

REPLACEMENT CONTROL ARM ASSEMBLIES

IF THERE IS A SEPARATION OF THE BALL STUD FROM THE HOUSING, THE DRIVER CAN LOOSE STEERING CONTROL, POSSIBLY RESULTING IN A VEHICLE CRASH.

FEDERAL-MOGUL WILL NOTIFY OWNERS OF RECORD AND REPLACE THE AFFECTED CONTROL ARMS FREE OF CHARGE. THE SAFETY RECALL BEGAN ON JANUARY 28, 2011. OWNERS MAY CONTACT FEDERAL-MOGUL AT 1-877-489-6659.

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.

CORP. MICRO BIRD 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 JANUARY 11, 2011. OWNERS MAY CONTACT TRANS/AIR WARRANTY AND SERVICE CENTER AT 1-800-673-2446.

CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA. The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have fail

Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpectedly because of a power surge, causing a diode to burn out.

The firm has issued notification letters via Federal express with reply verification tracking forms. A follow up letter and telephone survey as needed will be sent to follow up with non-responders. The firm is asking its consignees to return any recalled product. If there are any questions, please call 1.408.935.4952.

Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.

Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

On May 5, 2006 a letter was issued to all consignees, via return receipt requested. The letter advised consignees of the issue and provided some ways to mitigate the risk. Anyone experiencing the anomaly is to document the failure and report it to the firm. A field service representative will visit each consignee to optimize the antenna system to reduce intermodulations. After determining the root cause and validating a fix, the firm issued a second letter dated August 21, 2006 to their consignees. The letter advised consignees of three issues that needed 'improvement' and stated a service engieneer will schedule a time to visit and install the improvements.

One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.

Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.

Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affected Lot 2829235; request all recalled inventory from customers; call Carolina Logistics for an RGA; and when only the affected returned product is received, a credit will be issued.

Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA.

Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.

Recall initiated on December 10, 2008. A product recall letter and reply form were cent to CELL-DYN Sapphire customers who received syringes between September 16, 2008 and October 28, 2008 to US customers, and to November 5, 2008 for Outside-of-US customers.