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Modern Biomedical

“Modern has the ability to understand and fulfill our clients needs while meeting and exceeding their expectations. A customers expectation of equipment readiness is met through combining a quick response with technical expertise to achieve minimal downtime and effective cost containment. In a nutshell, solving problems is what we do. Our clients are able to relax and focus their efforts elsewhere”
– Randy Bullard, President/CEO

August 2012 - vol. 21:08

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: CAREFUSION 303 Inc., San Diego, CA. Alaris PC unit. Firm initiated recall ongoing. Firm notified users by letter on May 25th, 2012. Volume in Commerce: 106,888 units in US. Reason: The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code (120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen. FDA recall #Z-2076-2012. FDA Enforcement Report, 8/1/12.

CLASS I RECALL: CAREFUSION 303 Inc., San Diego, CA. Alaris Pump Module Model 8100. Firm initiated recall ongoing. Firm notified users by letter on June 29th, 2012. Volume in Commerce: 102,248 units. Reason: The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module (model 8100). Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011. FDA recall #Z-2185-2012. FDA Enforcement Report, 8/22/12.

CLASS I RECALL: GE OEC MEDICAL SYSTEMS, Inc., Salt Lake City, UT. OEC 9800. Firm initiated recall ongoing. Firm notified users by letter on Feb. 22nd, 2008. Volume in Commerce: 8,214 units. Reason: The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure. FDA recall #Z-2038-2012 FDA Enforcement Report, 8/1/12.

CLASS I RECALL: GE OEC MEDICAL SYSTEMS, Inc., Salt Lake City, UT. OEC 6800 Miniview, 8800 Flexview. Firm initiated recall completed. Firm notified users by letter on Nov. 20th, 2006. Volume in Commerce: 1,797 units. Reason: The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot. FDA recall #Z-2040-2012. FDA Enforcement Report, 8/1/12.

CLASS I RECALL: GE OEC MEDICAL SYSTEMS, Inc., Salt Lake City, UT. Radiological Image Processing System. Firm initiated recall completed. Firm notified users by letter on April 2nd, 2007. Volume in Commerce: 17 units. Reason: The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image. FDA recall #Z-2136-2012. FDA Enforcement Report, 8/15/12.

CLASS I RECALL: NELLCOR PURITAN BENNETT (DBA COVIDIEN LP), Boulder, CO. Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes. Firm initiated recall ongoing. Firm notified users by letter on July 18th, 2012. Volume in Commerce: 337,227 units. Reason: Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients. FDA recall #Z-2174-2012. FDA Enforcement Report, 8/22/12.

CLASS I RECALL: RESPIRONICS, Inc., Murrysville, PA. Respironics Trilogy 100, 200 and 202 Ventilators. Firm initiated recall ongoing. Firm notified users by letter on April 27th, 2012. Volume in Commerce: 173 units. Reason: The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. FDA recall #Z-2024-2012. FDA Enforcement Report, 8/1/12.

CLASS I RECALL: SMITHS MEDICAL ASD, Inc., Saint Paul, MN. MEDFUSION Syringe Infusion Pump, Model 4000. Firm initiated recall ongoing. Firm notified users by letter on Feb. 14th, 2012. Volume in Commerce: 257 pumps in US. Reason: Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation. FDA recall #Z-2107-2012. FDA Enforcement Report, 8/8/12.

CLASS I RECALL: STRYKER INSTRUMENTS DIV. OF STRYKER CORP., Portage, MI. Neptune Waste Mangement System. Firm initiated recall ongoing. Firm notified users by letter on June 8th, 2012. Volume in Commerce: 20,329 total units. Reason: Stryker received one report of a fatality from a customer in which the Neptune Rover was connected to a passive chest drainage tube post-operatively. Connecting the Neptune Rover (a high vacuum/high flow device), instead of using a post-operative low suction application, may have resulted in hemorrhage, which led to death. FDA recall #Z-2061/2064-2012. FDA Enforcement Report, 8/22/12.

ADVANCED STERILIZATION PRODUCTS, Irvine, CA. STERRAD Cyclesure Biological Indicator. Class II. Firm initiated recall ongoing. Firm notified users by press release on June 28th, 2012. Volume in Commerce: 38,693 units. Reason: Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life. FDA recall #Z-2100-2012. FDA Enforcement Report, 8/8/12.

BEEKLEY CORPORATION, Bristol, CT. Bella Blanket Protective Coverlet for Mammography. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 2nd, 2012. Volume in Commerce: 86,000 units. Reason: Imaging artifact can occur on mammogram result. FDA recall #Z-2080-2012. FDA Enforcement Report, 8/1/12.

GE OEC MEDICAL SYSTEMS, INC., Salt Lake City, UT. OEC 9800, Miniview 6800, Uroview 2800, Flexview 8800. Class II. Firm initiated recall terminated. Firm recall initiation date March 27th, 2007. Volume in Commerce: 82 total. Reason: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached. FDA recall #Z-2125/2127-2012. FDA Enforcement Report, 8/8/12.

GETINGE USA INC., Rochester, NY. Large Capacity Floor Loading Jet Spray Washer. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 25th, 2012. Volume in Commerce: 8 units. Reason: Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 5/4/09 through 9/26/11. This action is based on a report from the ground fault breaker manufacturer of a production error. FDA recall #Z-2079-2012. FDA Enforcement Report, 8/1/12.

HILL-ROM INC., Batesville, IN. Affinity Four Birthing Bed. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 2nd, 2012. Volume in Commerce: 12,726 units. Reason: During review of the last braking system via field corrective action, the system still did not meet expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural placement, episiotomy incision, vacuum extraction, forceps delivery, suprapubic pressure). In an effort to further improve the braking system of the Affinity Four Birthing Bed, Hill-Rom developed an enhanced brake detent assembly. FDA recall #Z-2082-2012. FDA Enforcement Report, 8/1/12.

KIMBERLY-CLARK CORPORATION, Roswell, GA. Patient Warming System. Class II. Firm initiated recall ongoing. Firm notified users by two or more of the following: email, fax, letter, press release, telephone or visit on April 27th, 2012. Volume in Commerce: 129 units. Reason: A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke. FDA recall #Z-2181-2012. FDA Enforcement Report, 8/15/12.

LEICA MICOSYSTEMS, INC. Buffalo Grove, IL. Leica M525 F50 Surgical Microscope. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 4th, 2012. Volume in Commerce: 39 units in US. Reason: Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter. FDA recall #Z-2053-2012. FDA Enforcement Report, 8/1/12.

ORTHO-CLINICAL DIAGNOSTICS, Rochester, NY. VITROS 5.1 FS System, 4600 Chemistry System, 5600 Integrated System Software. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 21st, 2012. Volume in Commerce: 3,508 units. Reason: Software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment. FDA recall #Z-2066/2068-2012. FDA Enforcement Report, 8/1/12.

PHILIPS HEALTHCARE INC., Andover, MA. Philips MultiDiagnost Eleva. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 11th, 2012. Volume in Commerce: 41 units. Reason: When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. FDA recall #Z-2156-2012. FDA Enforcement Report, 8/15/12.

SIEMENS HEALTHCARE DISGNOSTICS, INC. Newark, DE. Dimension Reagent Management System (RMS) power cord. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 17th, 2012. Volume in Commerce: 2,554 units. Reason: Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected. FDA recall #Z-2182-2012. FDA Enforcement Report, 8/15/12.