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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

January 24, 2011 - vol. 20:02

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.

B. BRAUN MEDICAL INC., Carrollton, Texas. Infusion System: Outlook 400ES Safety Infusion System, Model Number 621-400ES. Class I. Firm initiated recall ongoing. Firm notified users by letter on August 24, 2010. Volume in Commerce: 1,432 pumps: New York and Virginia. Reason: Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation. FDA recall #Z-0837-2011. FDA Enforcement Report, 01/19/11.

ABBOTT POINT OF CARE, INC., Princeton, New Jersey. Analyzers: 1)i-STAT Analyzer, Model 200; 2) FUSO Analyzer 300F; 3) i-STAT1 Abaxis Analyzer, Model 200; 4) Military Kit i-STAT1; 5) i-STAT Portable Clinical Analyzer, Model 200; 6) Military Kit Portable Clinical Analyzer, Model 2000. Class II. Firm initiated recall ongoing. Firm notified users by letters dated September 20, 2010. Volume in Commerce: 61,473 units. Reason: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component. FDA recalls #Z-0593/0598-2011. FDA Enforcement Report, 01/05/11.

ADVANCED STERILIZATION PRODUCTS, Irvine, California: Manufacturer: Minntech Corp., Plymouth, Minnesota. ASP Automatic Endoscope Reprocessor (AER). Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 19, 2010. Volume in Commerce: 1,881 units. Reason: ASP received three customer reports of elevated temperature of the high-level disinfectant solution used in the ASP AER as a result of a possible temperature monitoring system malfunction. This recall communication advised consignees that if high-level disinfectants are exposed to elevated temperatures, fumes may occur and result in reported incidents of respiratory reactions, dizziness, burning eyes, and headaches to the healthcare worker. FDA recall #Z-0628-2011. FDA Enforcement Report, 01/19/11.

BERCHTOLD CORP., N Charleston, South Carolina: Manufacturer: Berchtold Gmbh & Co Kg, Turlington, Germany. Surgical Lighting System: CHROMOPHARE Surgical Lighting System and CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 16, 2009. Volume in Commerce: 7,031 arms. Reason: A mechanical failure of a welded joint within the spring arm may result in the rapid drop of a monitor to the mechanical stop. FDA recall #Z-0591-2011. FDA Enforcement Report, 01/05/11.

BUNNELL, INC., Salt Lake City, Utah. Ventilator: 1) One Cat. Life Pulse High Frequency Ventilator Catalog Number: 203A; 2) One Cat. Life Pulse High Frequency Ventilator, Catalog 203. Class II. Firm initiated recall ongoing. Firm notified users by letter starting October 22, 2010. Volume in Commerce: 660 units. Reason: Product software coding error may compromise patient safety. FDA recalls #Z-0901/0902-2011. FDA Enforcement Report, 01/19/11.

CARDIAC SCIENCE CORP., Bothell, Washington: Manufacturer: Cardiac Science Corp., Deerfield, Wisconsin. Defibrillator/Monitor: GE Responder 2000, models 2025653, 2026109, and 2026114. Class II. Firm initiated recall ongoing Firm notified users by letter dated April 28, 2010. Volume in Commerce: 130 units. Reason: Some units may be non-operational during a rescue due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient’s heart rhythm or deliver therapy during a rescue. FDA recall #Z-0589-2011. FDA Enforcement Report, 01/05/11.

CARL ZEISS MEDITEC INC., Dublin, California. Surgical Microscope: VISU 200 on S8 Floor Stand. Class II. Firm initiated recall ongoing. Firm notified users by letter dated May 18, 2009. Volume in Commerce: 2,540 units. Reason: Potential Retina Damage – An error in the user manual may result in misapplied filter and injury during treatment. FDA recall #Z-0904-2011. FDA Enforcement Report, 01/19/11.

C.R. BARD, INC., Urological Division, Covington, Georgia: Manufacturer: Dymax Corp., Warrendale, Pennsylvania. Monitor: Bard CritiCore Monitor - software version 2.1. Class III. Firm initiated recall ongoing. Firm notified users by letter on or about November 18, 2010. Volume in Commerce: 234 units. Reason: Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container. FDA recall #Z-0719-2011. FDA Enforcement Report, 01/19/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin. CT Scanner: 24 individual recalls for HiSpeed LXI, LX/1, DX/I, and FX/I units. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 1, 2010. Volume in Commerce: 102 units. Reason: A defect with the hardware and software displaying the incorrect dose data. FDA recalls #Z-0744/0747, 0768, 0770/0788-2011. FDA Enforcement Report, 01/19/11.

INSTRUMENTATION LABORATORY CO., Bedford, Massachusetts. Coagulation Analyzer: 1) ACL 8000; 2) ACL 9000; 3) ACL 10000; 4) ACL ELITE; 5) ACL ELITE PRO. Class II. Firm initiated recall ongoing. Firm notified users by letter November 11, 2010. Volume in Commerce: 1059 units. Reason: Sporadically lowered APTT results were observed with the PT/APTT Test Groups. FDA recalls #Z-0803/0807-2011. FDA Enforcement Report, 01/19/11.

KREUZER Gmbh & CO., KG, Purcheim, Germany. Operating Table: klinoPORT, AC powered. Class II. Firm initiated recall ongoing. Firm notified users by letter on/about October 26, 2010. Volume in Commerce: 15 units. California, Massachusetts, and Missouri. Reason: The motorized adjustable pendant arm may suddenly descend to its lowest position. FDA recall #Z-0802-2011. FDA Enforcement Report, 01/19/11.

LINVATEC CORP. dba CONMED LINVATEC, Largo, Florida. Power cord Reel: 1) Power Cord reel: REF, VP6547, Power Cord Reel, Rx only; 2) Video Cart, Premium 120V; 3) Video Cart, Multi-Specialty; 4) Video Cart Articulating Arm; 5) Video Cart, 120 VAC. Class II. Firm initiated recall ongoing. Firm notified users by letter February 23, 2010. Volume in Commerce: 1,761 carts. Reason: There is a possibility that the Video Carts with retractable cord reels contain an Electric-cord plug which may fail. Such a failure could potentially interrupt surgery and may cause sparking, charring, or fire at the electrical wall socket. FDA recalls #Z-0847/0851-2011. FDA Enforcement Report, 01/19/11.

MEDTRONIC NAVIGATION, INC., Louisville, Colorado . Polaris Spectra System Control Unit: Component of the StealthStation S7 System. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 5, 2010. Volume in Commerce: 48 units. Reason: Electronic surgical navigation aid may lose tracking ability or stop working. FDA recall #Z-0715-2011. FDA Enforcement Report, 01/12/11.

OHIO MEDICAL CORP., Gurnee, Illinois. Portable Suction: Care E Vac 3 – diode and replacement screw. Class II. Firm initiated recall ongoing. Firm notified users by letter November 4, 2010. Volume in Commerce: 4,183 units. Reason: The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened. FDA recall #Z-0833-2011. FDA Enforcement Report, 01/19/11.

PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD, Shenyang, Liaoning, China. CT Scanner System: NeuViz Dual Series. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 10, 2010. Volume in Commerce: 26 units. Reason: Potential for the CT patient table top to become detached from the carrier due to missing washers. FDA recall #Z-0846-2011. FDA Enforcement Report, 01/19/11.

STERIS CORP., Mentor, Ohio: Manufacturer: Steris Corp., Montgomery, Alabama. Cmax Surgical Tables: Model # Cmax 110 and Cmax 220. Class II. Firm initiated recall ongoing. Firm notified users by letter dated August 26, 2010. Volume in Commerce: 1,635 units. Reason: Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is depressed on the hand control keypad. FDA recall #Z-0624-2011. FDA Enforcement Report, 01/12/11.

STERIS CORP., Mentor, Ohio: Manufacturer: Steris Canada, Beauport, Canada. Reliance EPS Endoscope Processing System. Class II. Firm initiated recall ongoing. Firm notified users by letter dated July 2, 2010. Volume in Commerce: 936 units. Reason: Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced. FDA recall #Z-0823-2011. FDA Enforcement Report, 01/19/11