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Around the MBI Circuit

Modern Biomedical

January 2013 - vol. 22:01

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.

CLASS I RECALL: GE HEALTHCARE, LLC. , Waukesha, WI. GE Giraffe and Panda T- Piece Resuscitation System. Firm initiated recall ongoing. Firm notified users by letter on June 26th, 1012. Volume in Commerce: 209,805 circuits. Reason: Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure. FDA recall #Z-0606-2013. FDA Enforcement Report, 1/2/13.

CLASS I RECALL: PRAXAIR INC., Danbury, CT. Vantage Grab n Go Gas Cylinder Pressure Regulator. Firm initiated recall ongoing. Firm notified users by letter Nov. 16th, 2012. Volume in Commerce: 255,690 units. Reason: Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. FDA recall #Z-0525-2013. FDA Enforcement Report, 1/2/13.

ADVANCED STERILIZATION PRODUCTS, Irvine, CA. STERRARD NX Cassettes PN 10133. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 20th, 2012. Volume in Commerce: 12,280 units. Reason: Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life. FDA recall #Z-0661-2013. FDA Enforcement Report, 1/16/13.

AMS INNOVATIVE CENTER, San Jose, CA. Greenlight HPS and XPS. Class II. Firm initiated recall ongoing. Firm notified users by letter on Dec. 11th, 2012. Volume in Commerce: 389 devices. Reason: During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard. FDA recall #Z-0700-2013. FDA Enforcement Report, 1/30/13.

HOSPIRA INC., Lake Forest, IL. Plum A+ Single Channel Infusion Pumps. Class II. Firm initiated recall ongoing. Firm notified users by letter on Dec. 7th, 2012. Volume in Commerce: 326,612 units. Reason: The door roller assembly on the Plum A+/A+3 family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. FDA recall #Z-0624/0626-2013. FDA Enforcement Report, 1/9/13.

PHILIPS MEDICAL SYSTEMS, Cleveland, OH. Computed Tomography X Ray System. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 28th, 2012. Volume in Commerce: 265 units. Reason: Philips has issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW. FDA recall #Z-0479-2013. FDA Enforcement Report, 1/2/13.

PHILIPS MEDICAL SYSTEMS, Cleveland, OH. Brilliance 64 and Ingenuity CT Computed Tomography X Ray Scanning System. Class II. Firm initiated recall ongoing. Firm notified users by letter on Dec. 3rd, 2012. Volume in Commerce: 3 units. Reason: Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to device users, device service personnel or patients undergoing scans. FDA recall #Z-0674-2013. FDA Enforcement Report, 1/23/13.

ROCHE DIAGNOSTICS OPERATIONS, INC., Indianapolis, IN. COBAS INTEGRA 400 and 400 plus Analyzer. Class III. Firm initiated recall ongoing. Firm notified users by letter on Nov. 19th, 2012. Volume in Commerce: 845 units. Reason: A software security issue with Oracle, TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access over the network to the Roche product and read and write database queries without authentication and therefore modify the content of a database. FDA recall #Z-0696-2013. FDA Enforcement Report, 1/30/13.

STRYKER COMMUNICATIONS INC., Flower Mound, TX. Visum Halogen Surgical Light. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 25th, 2012. Volume in Commerce: 1,082 units. Reason: Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete engagement of the Spring Arm Circlip. FDA recall #Z-0657-2013. FDA Enforcement Report, 1/16/13.

STRYKER INSTRUMENTS DIV. OF STRYKER CORPORATION, Portage, MI. Medical Surgical Bed. Class II. Firm notified users by two or more of the following: email, letter, fax, press release, telephone, or visit on Dec. 18th, 2012. Volume in Commerce: 1,013 units. Reason: Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15th , 2012 and May 23rd, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. FDA recall #Z-0628/0629-2013. FDA Enforcement Report, 1/9/13.

ZOLL CIRCULATION, INC., Sunnyvale, CA. AutoPulse Resuscitation System Model 100. Class II. Firm initiated recall ongoing. Firm notified users by letter on Aug. 8th, 2012. Volume in Commerce: 3,881 units. Reason: Complaints have been reported associated with an unexpected stop in AutoPulse compressions. FDA recall #Z-0658-2013. FDA Enforcement Report, 1/16/13.