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May 2012 - vol. 21:05

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: NELLCOR PURITAN BENNETT INC., (dba Covidien LP), Boulder, CO. Manufacturer: Covidien LLC, Norwood, MA. BIS Bilateral Sensors. Firm initiated recall ongoing. Firm notified users by letter on November 8th, 2011. Volume in Commerce: 8,510 units (851 boxes of 10). Reason: During manufacture, circuit traces were reversed which causes inaccurate display of information. FDA recall #Z-0802-2012. FDA Enforcement Report, 5/2/12.

GE HEALTHCARE, LLC, Waukesha, WI. GE Healthcare Automatic Mobile X-Ray (AMX) series. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 23rd, 2011. Volume in Commerce: 130 units. Reason: GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product related to the light field to x-ray field edge alignment. FDA recall #Z-1399-2012. FDA Enforcement Report, 5/9/12.

HOSPIRA INC., Lake Forest, IL. Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. LifeShield Primary Plumset. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 25th, 2012. Volume in Commerce: 145,875 sets. Reason: The LifeShield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention. FDA recall #Z-1491-2012. FDA Enforcement Report, 5/16/12.

ORTHO-CLINICAL DIAGNOSTICS, Rochester, N.Y. VITROS Immunodiagnostic System. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 15th, 2012. Volume in Commerce: 776 units. Reason: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. FDA recall #Z-1468/1472-2012. FDA Enforcement Report, 5/16/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance & GEMINI X Ray Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 26th, 2012. Volume in Commerce: 1,110 units. Reason: TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list. FDA recall #Z-1366/1369-2012. FDA Enforcement Report, 5/2/12.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Allura X-ray System. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 27th, 2012. Volume in Commerce: 145 units. Reason: The monitor Ceiling suspension may fail, which may cause the monitor to drop. FDA recall #Z-1462-2012. FDA Enforcement Report, 5/9/12.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Philips Digital Diagnost Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 30th, 2012. Volume in Commerce: 153 units in US. Reason: Potential misdiagnosis due to improper automatically stitched images and improper image ruler handling. FDA recall #Z-1464-2012. FDA Enforcement Report, 5/23/12.

SCOTTCARE CORP., Cleveland, OH. TeleSentry Multi-parameter Ambulatory Telemetry. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 19th, 2012. Volume in Commerce: 513 units. Reason: Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card and the device stops working. FDA recall #Z-1400-2012. FDA Enforcement Report, 5/2/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Malvern, PA. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. AXIOM Artis and AXIOM Artis zee modular systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 16th, 2012. Volume in Commerce: 45 units. Reason: There is a potential misalignment in the connection of the remote foot switch and the stationary unit. FDA recall #Z-0927-2012. FDA Enforcement Report, 5/2/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Siemens AG, Medical Solutions, Kemnath, Germany. Linear accelerator with a 550 TxT Treatment Table. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 3rd, 2012. Volume in Commerce: 624 active devices. Reason: Siemens has received reports where a dropping down of the 550 TxT Treatment Table was observed while the table was being moved downwards during operation by means of the hand control. FDA recall #Z-1486-2012. FDA Enforcement Report, 5/16/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Siemens AG, Medical Solutions, Kemnath, Germany. ARTISTE or ONCOR Linear Accelerators with Multi Leaf Collimator. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 3rd, 2012. Volume in Commerce: 290 units. Reason: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the “Motion Stop” button followed by “Reset” several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2). FDA recall #Z-1493-2012. FDA Enforcement Report, 5/16/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Siemens AG, Medical Solutions, Kemnath, Germany. Siemens branded ONCOR or PRIMUS linear accelerator. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 4th, 2012. Volume in Commerce: 73 units. Reason: The firm became aware of a potential issue with Siemens branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury. FDA recall #Z-1494-2012. FDA Enforcement Report, 5/23/12.

SMITH & NEPHEW, INC. Endoscopy Division, Andover, MA. Manufacturer: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK. Smith & Nephew 560P High Definition Camera Control Unit. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 29th, 2012. Volume in Commerce: 239 units. Reason: May experience intermittent loss of video due to a defective board component. FDA recall #Z-1479-2012. FDA Enforcement Report, 5/16/12.

STRYKER MEDICAL DIVISION OF STRYKER CORP., Portage, MI. Stryker Beds (Epic Critical, Epic Zoom, Secure & Critical). Class II. Firm initiated recall ongoing. Firm notified users by letter on March 12th, 2012. Volume in Commerce: 68,725units. Reason: Plate Body Installed on Secure II and EPIC units since November 21st, 2007 and installed on units upgraded between 9/1/2004 through 11/20/2007, demonstrated a component life of approx. 2 years of simulated use. While the correct brake plates were installed on these beds, updated maintenance information was not included. Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. FDA recall #Z-1036-2012. FDA Enforcement Report. 5/2//12.

VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS, Palo Alto, CA. FastPlan Treatment Planning System. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 30th, 2012. Volume in Commerce: 201 units. Reason: An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the user elects to “Discard” that slice, an incorrect calculation of the isocenter location may result. FDA recall #Z-1217-2012. FDA Enforcement Report, 5/9/12.