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Modern Biomedical

January 2012 - vol. 21:01

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

FDA MEDWATCH – CLASS I RECALL: Respironics, Inc. Trilogy 100 Ventilators. FDA notified healthcare professionals of a class I recall due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient. RECOMMENDATION: Respironics notified its US distributors, providers, sales personnel and customers of the recall by telephone on October 11, 2011. The company will continue to notify affected customers to arrange for the return or repair of all recalled ventilators. FDA posted 1/12/12.

CLASS I RECALL: INO THERAPEUTICS, Madison, WI. INOmax DS (Delivery System) Model 10003 & 10007. Firm initiated recall on going. Firm notified users by letter on December 22nd, 2011. Volume in Commerce: 2446 units. Reason: Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR 806.10. FDA recall #Z-0583-2012. FDA Enforcement Report, 1/4/12.

CLASS I RECALL: CAREFUSION 211 INC., Yorba Linda, CA. Manufacturer: Carefusion 207 Inc., Palm Springs, CA. AVEA Ventilator. Firm initiated recall on going. Firm notified users by letter on September 25th, 2011. Reason: The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilator and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk. FDA recall #Z-0510-2012. FDA Enforcement Report, 1/11/12.

AGFA CORP., Greenville, SC. Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Agfa Computed Radiography Systems with DX-G Digitizer. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 6th, 2011. Volume in Commerce: 124 units. Reason: Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during start up or during a cassette scan cycle. FDA recall #Z-0591-2012. FDA Enforcement Report, 1/18/12.

BECKMAN COULTER INC., Brea, CA. Manufacturer: Beckman Coulter Inc., Miami, FL. Coulter Hematology Analyzer. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 13th, 2011. Volume in Commerce: 222 units. Reason: Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. FDA recall #Z-0599/0602-2012. FDA Enforcement Report, 1/4/12.

GE HEALTHCARE, LLC., Waukesha, WI. Manufacturer: GE Medical Systems Information Technology, Wauwatosa, WI. GE Logiq E9 Diagnostic Ultrasound Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 20th, 2011. Volume in Commerce: 894 units. Reason: GE Healthcare has recently become aware of a potential safety issue associated with the data of the Logiq E9 system that may impact patient safety. User may notice and image from a different patient, or an image from the current patient with title information from a different patient or incorrect measurements / calculations on images when viewed on the off-line review station. As a result imaging may need to be repeated due to the confusion in the image information. FDA recall #Z-0705-2012. FDA Enforcement Report, 1/18/12.

INTERSURGICAL INC., Liverpool, NY. Manufacturer: Intersurgical Ltd., Guernsey, UK. IS Can Disposable CO2 absorber x 6 on GE rebreathing systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 8th, 2011. Volume in Commerce: 2,216 cans. Reason: Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system. FDA recall #Z-0518-2012. FDA Enforcement Report, 1/18/12.

MAQUET CARDIOVASCULAR US SALES, LLC., Wayne. NJ. Maquet Quadrox iD Pediatric Oxygenator. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 22, 2011. Volume in Commerce: 168 units. Reason: There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oxygenator. FDA recall #Z-0689-2012. FDA Enforcement Report, 1/18/12.

MIDMARK CORP., Versailles, OH.. M11 Ultra Steam Sterilizer. Class II. Firm initiated recall ongoing. Firm notified users by letters the week of January 9th, 2012. Volume in Commerce: 30,255 units. Reason: During a FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. FDA recall #Z-0597-2012. FDA Enforcement Report, 1/11/12.

OLYMPUS AMERICA INC., Center Valley, PA. Manufacturer: Celon AG Medical Instruments, Teltow, Germany. Olympus Electrosurgical Unit. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 28th, 2011. Volume in Commerce: 245 units. Reason: Investigations of customers complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100. FDA recall #Z-0747-2012. FDA Enforcement Report, 1/18/12.

PHILIPS MEDICAL SYSTEMS, San Jose, CA., Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Extended Brilliance Workstation. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 27th, 2011. Volume in Commerce: 1,181 systems. Reason: A problem related to a software error has been detected. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur. FDA recall #Z-0182-2012. FDA Enforcement Report, 1/11/12.

PHILIPS MEDICAL SYSTEMS, San Jose, CA. Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. SKYlight Imaging Systems, Model 882050. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 8th, 2011. Volume in Commerce: 129 units. Reason: During preventive maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner. FDA recall #Z-0607-2012. FDA Enforcement Report, 1/18/12.

SMITHS MEDICAL, Rockland, MA., HOTLINE Disposable Administration Sets. Class II. Firm initiated recall ongoing. Firm notified users by telephone on November 28th, 2011. Volume in Commerce: 805,506 units. Reason: Disconnected / loose Luer connectors at the patient end of the triple lumen tubing of the HOTLINE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets. FDA recall #Z-0422/0428-2012. FDA Enforcement Report, 1/11/12.

SYNTHES USA INC., West Chester, PA. Synthes Oscillating Saw Attachment for Small Battery Drive. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 17th, 2011. Volume in Commerce: 5 units. Reason: The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and or user. FDA recall #Z-0348-2012. FDA Enforcement Report. 1/18/12.

TENET MEDICAL ENGINEERING, Calgary, Canada. Smith & Nephew, SPIDER2 Limb Postitioner. Class II. Firm initiated recall ongoing. Firm initiated recall is complete. Volume in Commerce: 52 units. Reason: SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage. FDA recall #Z-0519-2012. FDA Enforcement Report, 1/18/12.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Arbor, MI. CDI 101 Hematocrit / Oxygen Saturation Monitoring System. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 4th, 2011. Volume in Commerce: 366 units. Reason: Terumo has not submitted a 510(k) to FDA to market the device. FDA recall #Z-0604-2012. FDA Enforcement Report, 1/4/12.

VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS, Palo Alto, CA. Varian Linear Accelerators. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 9th, 2011. Volume in Commerce: 5,823 units. Reason: Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automatic mode. FDA recall #Z-0181-2012. FDA Enforcement Report. 1/18/12.