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June 2012 - vol. 21:06

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.

CLASS I RECALL: GE HEALTHCARE, LLC., Waukesha, WI. Aestiva/5 7900 SmartVent Anesthesia Machine. Firm initiated recall ongoing. Firm notified users by letter on April 10th, 2012. Volume in Commerce: 8 units. Reason: Potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of the Aestiva 7900 Anesthesia Device. There is potential for two vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This may cause prolonged or persistent hypotension requiring medical intervention. To date, no injury has been reported to GE Healthcare associated with this issue. FDA recall #Z-1787-2012. FDA Enforcement Report, 6/27/12.

CLASS I RECALL: MOOG Medical Devices Group, Salt Lake City, UT. Manufacturer: MOOG Medical Devices Group, Srl, Alajuela, Costa Rica. Microbore Administrative Set. Firm initiated recall ongoing. Firm notified users by letter and a press release on May 21st, 2012. Volume in Commerce: 409,300 sets. Reason: MOOG Medical Device Group became aware via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended. FDA recall #Z-1659/1672-2012. FDA Enforcement Report, 6/6/12.

CINCINNATI SUB-ZERO PRODUCTS, INC. Cincinnati,. OH. ECMO Heaters. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 31st, 2012. Volume in Commerce: 295 units. Reason: Design error. The probe jack contacts (terminals) on certain of the firm’s ECMO Heater devices are located to close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a service tech, operator / user, and / or patient could be exposed to electric shock during device servicing or use. FDA recall #Z-1656-2012. FDA Enforcement Report, 6/6/12.

COVIDIEN LP, North Haven, CT. Roticulator Single Use Stapler. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 9th, 2012. Volume in Commerce: 123,856 units. Reason: Potential for the sterility barrier to be comprised. FDA recall #Z-1844/1848-2012. FDA Enforcement Report, 6/27/12.

ETHICON ENDO-SURGERY INC., Cincinnati, OH. HPBLUE HARMONIC Blue Hand Piece. Class II. Firm initiated recall ongoing. Firm notified users by letter in March 2012. Volume in Commerce: 1,896 in US. Reason: The problem occurs after successful set-up and initial use of HARMONIC Hand Pieces with the Generator 300. The procedure is interrupted when the Generator 300 goes into stand-by mode after one minute of cumulative activation time (approx. 10 activations). Once the generator is in stand-by mode, the device cannot be activated to complete the procedure without fully re-setting the system. The problem will continue to occur each time the system is re-set and one minute of activation time is reached. FDA recall #Z-1673-2012. FDA Enforcement Report, 6/6/12.

GENERAL ELECTRIC MED SYSTEMS, Waukesha, WI. GE Healthcare Radiographic Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter (no specific date given). Volume in Commerce: 3,796 units. Reason: An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath. FDA recall #Z-1788/1790-2012. FDA Enforcement Report, 6/20/12.

ORTHO CLINICAL DIAGNOSTICS, Rochester, NY. VITROS 5600 Integrated System Software. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 26th, 2012. Volume in Commerce: 1,357 units. Reason: Recall because of an anomaly that may inadvertently add a surfactant to a CurveTip position. FDA recall #Z-1699-2012. FDA Enforcement Report, 6/6/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance iCT. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 8th, 2012. Volume in Commerce: 372 units. Reason: Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds. FDA recall #Z-1688-2012. FDA Enforcement Report, 6/6/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance 16, 40, Big Bore, iCT CT Scanning Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 27th, 2012. Volume in Commerce: 286 units. Reason: Component defect. The metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm’s CT scanning systems were not manufactured to specification and may crack. FDA recall #Z-1690/1693-2012. FDA Enforcement Report, 6/6/12.

PHILIPS MEDICAL SYSTEMS (Cleveland) Inc., Cleveland, OH. Brilliance iCT and iCT SP X Ray Systems. Class II. Firm initiated recall ongoing. Firm notified users by e-mail on May 7th, 2012. Volume in Commerce: 241 units. Reason: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances, including calibration ring artifacts that may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds. FDA recall #Z-1791-2012. FDA Enforcement Report, 6/20/12.

PLASMA SURGICAL INC., Roswell, GA. PlasmaJet Open Surgery Handpiece. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 27th, 2012. Volume in Commerce: 36 units. Reason: Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use. FDA recall #Z-1794-2012. FDA Enforcement Report, 6/13/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, CA. ACUSON S2000 Ultrasound Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 23rd, 2012. Volume in Commerce: 879 units. Reason: When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. FDA recall #Z-1684/1685-2012. FDA Enforcement Report, 6/6/12.

SPACELABS HEALTHCARE, LLC. Issaquah, WA. Pathfinder SL Holter Analyzer. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 11th, 2012. Volume in Commerce: 114 units. Reason: The firm received reports of the pathfinder SL software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker. FDA recall #Z-1831-2012. FDA Enforcement Report, 6/27/12.