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“Providing quality and cost-effective biomedical equipment services since 1978.”

Around the MBI Circuit

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

June 28, 2010 vol. 19:09

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.

BAUSCH & LOMB INC., Rochester, New York: Manufacturer: Bausch & Lomb Inc., Saint Louis, Missouri. Microsurgical System: 1) Millennium System Vit Enhancer (MVE); 2) Millennium Microsurgical System; 3) Stellaris Vision. All devices manufactured since 2004. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 1 9, 2009. Volume in Commerce: Unknown. Reason: The AC power cords used on these products are subject to an FDA Alert – Safety Investigation of Certain Medical Device Power Cords: Initial Communication. FDA recalls #Z-1662/1664-2010. FDA Enforcement Report, 06/23/10.

BECKMAN COULTER INC., Brea, California: Manufacturer: Beckman Coulter, Inc., Chaska, Minnesota. Reagent Kit: Access Immunoassay Systems Accu Tnl Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 5, 2010. Volume in Commerce: 196,071 kits. Reason: Different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained with UniCel Dxl systems have been demonstrated to have a positive bias compared to values obtained with Access or Access 2 Systems. . FDA recall #Z-1318-2010. FDA Enforcement Report, 06/23/10.

CARDIAC SCIENCE CORPORATION, Bothell, Washington. Defibrillator/Monitor: Responder 2000: Models 2025653, 2026109, and 2026114. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 15, 2009. Volume in Commerce: 1,838 units. Reason: The Operators Manual may not have adequate information to clearly explain device behaviors. Pressing and holding down the Charge or Shock button on the device for more than 5 seconds causes a “Button Stuck” error. With the “Button Stuck” error, the device will automatically exit Manual mode and enter Monitor mode. The user cannot apply therapy while the device is in Monitor mode. FDA recall #Z-1683-2010. FDA Enforcement Report, 06/23/10.

CONMED ELECTROSURGERY, Centennial, Colorado: Manufacturer: ConMed, Inc., Chihuahua, Mexico. Surgical Accessories – pencils, blade electrodes (12 models) Class II. Firm initiated recall ongoing. Firm notified users by letter on March 25, 2010. Volume in Commerce: 683,440 units – plus 114,350 internationally. Reason: Electrosurgical pencil may remain activated or self activate after power switch is released. FDA recalls #Z-1562/1573-2010. FDA Enforcement Report, 06/23/10.

CONVATEC, Skillman, New Jersey: Manufacturer: Techniko Medical Ltd., Bh21 6vs. Wimborner, UK. ECG Electrodes: Unilect for Cardiac Monitoring. Class II. Firm initiated recall is ongoing. Firm notified users by visit on March 9, 2010 and by letter dated March 11, 2010. Volume in Commerce: 567, 000 units. (189 cases). Reason: In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity. FDA recall #Z-1431-2010. FDA Enforcement Report, 06/23/10.

GE HEALTHCARE LLC, Waukesha, Wisconsin: Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Datex-Ohmeda Tusat Pulse Oximeter and Accessories: Model 3500. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated April 22, 2010. Volume in Commerce: 28,442 units. Reason: Device does not comply with current safety standards. It is possible that the external power supply could leak electrical current resulting in third degree burns or an abnormal heart rhythm that, if untreated, could lead to death. FDA recall #Z-1814-2010. FDA Enforcement Report, 06/23/10.

LEICA MICROSYSTEMS, INC., Bannockburn, Illinois: Manufacturer: Leica Biosystems Melborne Leica BSD International Pty Ltd., Mount Waverly, Australia. Tissue Processor: Peloris Rapid Tissue Processor. Class II. Firm initiated recall is ongoing. Firm notified users by letters February 9, 2010. Volume in Commerce: 574 units. Reason: Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve leakage have contributed to tissue damage during processing, leading to rebiopsies. FDA recall #Z-1551-2010. FDA Enforcement Report, 06/23/10.

NEWPORT MEDICAL INSTRUMENTS, INC., Costa Mesa, California. Ventilator: Newport e360 ventilator manufactured between September and December 2009 – (S/N N093609XXXXX, N093610XXXXX, N093611XXXXX, and N093612XXXXX). Class II. Firm initiated recall is ongoing. Firm notified users by letters dated April 14, 2010. Volume in Commerce: 990 units. Reason: The recall is the result of a recent increase in complaints related to the early failure of a low pressure transducer which is on PCB (Printed Circuit Boards) 2104A. All affected ventilators require the replacement of the PCB 2104A to avoid early failure of this pressure transducer. The failure results in pressure or volume alarms where P1 cannot be calibrated correctly or in a Device Alert alarm associated with a P1 failure. In most cases, the failure is detected at power on but failures can occur during ventilation. FDA recall #Z-1617-2010. FDA Enforcement Report, 06/23/10.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Defibrillator/Monitor: HeartStart MRx (Models M3535A, and M3536A). Class II. Firm initiated recall is ongoing. Firm notified users by letter dated April 7, 2009. Volume in Commerce: 1,379 units. Reason: ECG signal processing chip may fail causing failure to deliver therapy in AED mode or the failure to indicate poor electrical contact (very high impedance) with the patient in Manual Defib mode. FDA recall #Z-1618-2010. FDA Enforcement Report, 06/23/10.

STRYKER COMMUNICATIONS CORPORATION, Flower Mound, Texas: Manufacturer: JLT Engineering Products, Ltd., Bridgeport, Texas. Universal Flat Panel Yoke: a component of the Stryker Flat Panel Arm. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated April 19, 2010. Volume in Commerce: 676 units. Reason: Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel. FDA recall #Z-1605-2010. FDA Enforcement Report, 06/23/10.

STRYKER ENDOSCOPY, San Jose California. Imaging Device: for medical procedures to provide surgeons or operating personnel the ability to capture still images and to record video during the procedures in various file formats that can be transferred to external media – SDC HD units and SDC HDi units. Class II. Firm initiated recall is ongoing. Firm notified users by letter on October 23, 2009. Volume in Commerce: 12,825 units. Reason: Video device is not able to assign the correct time/date stamp. FDA recall #Z-1590-2010. FDA Enforcement Report, 06/23/10.