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April 2010: vol. 19:04

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.

Update: Class I – CARDIAC SCIENCE CORPORATION, Bothell, Washington: Manufacturer: Cardiac Science Corporation, Deerfield, Wisconsin. Defibrillator: Automated External Defibrillators: a) Cardiac Science - 7 Powerheart Models: 9300 A, C, D, E, P, and 9390 A and E; b) Burdick 3 Cardiovive Models: 92331, 92532, and 92532; c) GE - 2 Responder Models: 2019198, 2023440; d) NK 2 CardioLife Models: 9231, and 9200G. Class I. Firm initiated recall ongoing. Firm first notified users by letter dated November 13, 2009. Volume in Commerce: 284,800 units. Reason: Potential for devices not to deliver therapy. FDA recalls #Z-0765/0778-2010. FDA Enforcement Report, 03/31/10.

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ABBOTT POINT OF CARE., INC., Princeton, New Jersey. I-STAT 1 Analyzer: no lot or serial number. Class II. Firm initiated recall ongoing. Firm notified users by letter during September 2009. Volume in Commerce: 3,918 units. Reason: The storage temperature on the label on the side of the I-Stat Portable Clinical Analyzer shipping box does not match product specification. FDA recall #Z-0812-2010. FDA Enforcement Report, 03/17/10.

ABBOTT POINT OF CARE., INC., Princeton, New Jersey. Printer: Martel Printer accessory to the I-Stat analyzer, model 300. Class II. Firm initiated recall ongoing. Firm notified users by letter dated October 2009. Volume in Commerce: 5,224 units. Reason: Some printers have the potential of being damaged due to the use of rechargeable battery packs that do not contain a fuse. FDA recall #Z-1133-2010. FDA Enforcement Report, 03/24/10.

BECKMAN COULTER, INC., Brea, California: Manufacturer: Beckman Coulter Inc., Fullerton, California. Access Peristaltic Pump: component of Access Immunoassay Systems - UniCel Dxi 800, 600, & Unicel DxC880i. Class II. Firm initiated recall ongoing. Firm notified users by letter dated October 16, 2008. Volume in Commerce: 114 units. Reason: Premature failure of the upper aspirate peristaltic pump which may negatively affect precision. The upper peristaltic pump assembly may not maintain a proper flow rate. FDA recall #Z-0914-2010. FDA Enforcement Report, 03/17/10.

BECKMAN COULTER, INC., Brea, California: Manufacturer: Beckman Coulter Inc., Fullerton, California. SlideMaker: a_ Coulter LH SlideMaker; b) GEN*S SlideMaker. Class II. Firm initiated recall ongoing. Firm notified users by letter dated June 9, 2008. Volume in Commerce: 847 units. Reason: The Sample ID information embedded in the barcode affixed to a slide made by the devices does not match the text.. FDA recalls #Z-0850/0851-2010. FDA Enforcement Report, 03/17/10.

ENCOMPASS THERAPEUTIC SUPPORT SYSTEMS, dba BG North America, Glendale, California: Manufacturer: KAP Medical, Corona, California and Leach Battery Corp., Garden Grove, California. Alternating Pressure Therapy: AccMax Quantum Complete – Model CU3/CU4, an alternating pressure with turn assist & on demand low air loss system. Class II. Firm initiated recall ongoing. Firm notified users by letter dated March 5, 2010. Volume in Commerce: 349 units: California, Indiana, Missouri, Oregon, & Texas. Reason: Potential out gassing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire. FDA recall #Z-1216-2010. FDA Enforcement Report, 04/07/10.

HOSPIRA INC., Lake Forest, Illinois: Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredis, Costa Rica. IV Sets: a) LifeShield Latex-Free Primary SYMBIQ Set, list number 16096-28; b) LifeShield Latex-Free Primary I.V. Set, list number 19689-01. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 8, 2010. Volume in Commerce: 49,440 units. Reason: There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure. FDA recalls #Z-0808/0809-2010. FDA Enforcement Report, 03/03/10.

INTUITUVE SURGICAL INC., Sunnyvale, California. Endoscopic Instrument Control: da Vinci S Surgical System IS2000. Class II. Firm initiated recall ongoing. Firm notified users by e-mail and visit on July 1, 2009 and July 7, 2009. Volume in Commerce: 782 units. Reason: Gripper or scissor jaw may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect. FDA recall #Z-1161-2010. FDA Enforcement Report, 04/07/10.

MEDRAD INC., Indianola, Pennsylvania. Fluid Management Injection System: Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve. Class II. Firm initiated recall is complete. Firm notified users by letter dated January 6, 2010. Volume in Commerce: 2,625 units: Alabama, Arizona, California, DC, Florid, Georgia, Illinois, Kansas, Maryland, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin. Reason: The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging. FDA recall #Z-1199-2010. FDA Enforcement Report 03/31/10.

PELTON & CRANE CO., Charlotte, North Carolina. Dental Chairs: w/magnetic headrests: Chairman 5000, Spirit 1500, 1800, 2000, and 3000. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 9, 2010. Volume in Commerce: 498 chairs and 619 upholstery replacement parts. Reason: Magnetic headrests may affect patients with implantable pacemakers and defibrillators. FDA recalls #Z-1179/1180-2010. FDA Enforcement Report, 04/07/10.

PHILLIPS HEALTHCARE, INC., Andover, Massachusetts. Defibrillator Paddles: Switched Internal Defibrillator Paddles used with HeartStart XL and Heartstart MRx – Models M4741A, M4742A, M4743A, & M4744. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 25, 2010. Volume in Commerce: 1,592 units. Reason: Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy. FDA recall #Z-1135-2010. FDA Enforcement Report, 03/24/10.

PHYSIO-CONTROL, INC., Redmond, Washington. Defibrillator: Biphasic LIFEPAK 12 defibrillator/monitor; no lot or serial number. Class II. Firm initiated recall ongoing. Firm notified users by letter during September 2009. Volume in Commerce: 1,718 units. Reason: Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient. FDA recall #Z-0811-2010. FDA Enforcement Report, 03/03/10.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC., Tustin, California: Manufacturer: Toshiba Electron Tubes & Devices Co., Ltd., Otawa-Shi, Tochigi, Japan. Ultrasound: a) Aplio 50; SSA-700A, software version 5.5r002; b) Aplio 80; SSA-770A, software version 5.5r002; c) Xario; SSA-660A, software version 1.0 and later. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 12, 2007. Volume in Commerce: 200 units. Reason: Firm initiated field corrective action because the product does not meet the Safety Standard requirements. FDA recalls #Z-1171/1173-2010. FDA Enforcement Report, 03/31/10.

STERIS CORP., Mentor, Ohio: Manufacturer: Steris Corp., Montgomery, Alabama. Surgical Lights: a)Harmony Lux Advantage LA, aka Harmony LA 500/700; b) Harmony Lux Advantage aka Harmony LC 5000. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 23, 2010. Volume in Commerce: 14,730 units. Reason: Premature bulb failure. FDA recalls #Z-1218/1220-2010. FDA Enforcement Report, 04/07/10.