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August 2011 - vol. 20:10

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.

FDA Med Watch

Silencer S2200 Centrifuge. Class I Recall – Biohazardous Materials May be Released - Global Focus Marketing, Ltd., Dallas, Texas; Initial Recall 7/15/11. There is a potential for a centrifuge’s bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge. This could result in a serious personal injury and the surrounding area. The silencer 2200 is a general purpose centrifuge designed to be used in educational, biochemistry, clinical or industrial laboratories. Its applications include urine and blood separations or other procedures where solids, particles or cells are separated from liquids. The model number can be found on the front of the centrifuge and the serial number can be found on the back. Customers who have one of these affected units should STOP using the S22000 and contact Global Focus Marketing & Distribution, Ltd.

GEM Premier 4000 PAK Cartridges. Class I Recall. Instrumentation Laboratory Company; Initial Recall 5/31/11. Potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus .5 mmol/L by as much as 2.0 mmo/L. Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. These products were manufactured and distributed from May 2006 through July 2011. Customers were directed to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting.

Class I: MAQUET DATASCOPE CORP. CARDIAC ASSIST DIVISION, Mahwah, NJ: Datascope / Maquet IABP’s. System 98/98XT Intra Aortic Balloon Pump. Class I. Firm initiated recall ongoing. Firm notified users by letter on March 16, 2011. Volume in Commerce: 885 units. Reason: Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan’s assembly which may cause the power supply to detect an overheating event and shut down. FDA recall #Z-2414-2011. FDA Enforcement Report 8/3/11.

Class I. GE HEALTHCARE, LLC, Waukesha, WI. Manufacturer: Vital Signs Inc., Totowa, NJ. Hygroscopic Condenser Humidifier (HCH) / Anesthesia Breathing Machine. Class I. Firm initiated recall ongoing. Firm notified users by telephone and letter on April 29th, 2011. Volume in Commerce: 222,009 units. Reason: The HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. FDA recall #Z- 2848-2011. FDA Enforcement Report, 8/10/11.

BARD ACCESS SYSTEMS, Salt Lake City, UT. Manufacturer: Dymax Corp., Warrendale, PA. Site Rite Vision Ultrasound System. Class II. Firm initiated recall ongoing. Firm notified users by letter in June 2011. Volume in Commerce: 86 units. Reason: Purchasing erroneously ordered the incorrect fan using the distributor’s part number instead of using the specified manufacturer part number. FDA recall #Z-2782-2011. FDA Enforcement Report, 7/27/11.

CARDIAC SCIENCE CORP., Bothell, WA. Manufacturer: Cardiac Science Corp., Deerfield, WI. Automated External Defibrillator. Class II. Firm initiated recall ongoing. Firm notified users by letters in August 2010 and March 2011. Volume in Commerce: 48,700 units. (41,396 Nationwide). Reason: Cardiac Science Corp. intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. FDA recall #Z-2917-2011. FDA Enforcement Report, 8/10/11.

GE HEALTHCARE, LLC, Waukesha, WI. Manufacturer: Vital Signs Inc., Totowa, NJ. Cuffable Blood Pressure Cuffs. Firm initiated recall ongoing. Firm notified users by letter on April 26th, 2011. Volume in Commerce: 2,684,996 units. Reason: BP cuffs may not properly inflate due to a leak. FDA recall #Z-2581-2011. FDA Enforcement Report, 8/3/11.

HITACHI MEDICAL SYSTEMS AMERCICA INC., Twinsburg, OH. Manufacturer: Hitachi Medical Corp., Chiyoda-Ku, Tokyo, Japan. Hitachi HIVISION Preirus/Avius Ultrasound. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 15th, 2011. Volume in Commerce: 24 systems. Reason: Software anomaly. The Doppler Trace Measurement feature on certain models of the firm’s diagnostic ultrasound systems may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity leading to the possible patient mis-diagnosis of vessel stenosis. FDA recall #Z-2467-2011. FDA Enforcement Report, 8/10/11.

MAQUET INC., Wayne, N.J. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Servo-i/s Ventilator Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 20th, 2011. Volume in Commerce: 75,503 units. Reason: Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes. FDA recall #Z-2628 / 2629-2011. FDA Enforcement Report, 8/3/11.

METTLER ELECTRONICS CORP., Anaheim, CA. Manufacturer: ZMI Electronics Ltd., Kaohsiung, Tawain. Mettler Traction Decompression System. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 14th , 2011. Volume in Commerce: 221 units. Reason: Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device MTD4000. Component failure might result in patient injury. FDA recall #Z-2580-2011. FDA Enforcement Report, 8/3/11.

NEWPORT MEDICAL INSTRUMENTS INC., Costa Mesa, CA. Newport HT50 Ventilator. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 13th, 2009. Volume in Commerce: 33 units. Reason: Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep the ventilators plugged into an external power supply whenever possible to preserve the long term capacity of the battery. FDA recall #Z-2295-2011. FDA Enforcement Report, 8/3/11.

NEWPORT MEDICAL INSTRUMENTS INC., Costa Mesa, CA. Newport HT50 Ventilator. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 14th, 2010. Volume in Commerce: 1,113 EP cases. Reason: The Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. FDA recall #Z-2382-2011. FDA Enforcement Report, 8/3/11.

NEWPORT MEDICAL INSTRUMENTS INC., Costa Mesa, CA. Newport HT70 Ventilator. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 20th, 2010. Volume in Commerce: 22 units. Reason: A limited number of power cords recently received from the supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power disconnect alarm. FDA recall #Z-2406-2011. FDA Enforcement Report, 8/3/11.

NEWPORT MEDICAL INSTRUMENTS INC., Costa Mesa, CA. Newport e360 Ventilator. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 27th, 2009. Volume in Commerce: 18 units. Reason: Some e360 ventilators were shipped with a different software version from what the customers ordered. FDA recall #Z-2468-2011. FDA Enforcement Report, 8/3/11.

PHILIPS MEDICAL SYSTEMS, San Jose, CA. Manufacturer: Philips Medical Systems Inc., Cleveland, OH. BrightView X/XCT Gamma Camera. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 8th, 2011. Volume in Commerce: 213 units. Reason: Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly. FDA recall #Z-2947/2949-2011. FDA Enforcement Report, 8/10/11.

PHYSIO CONTROL INC., Redmond, WA. 12-Lead ECG Cable Assembly. Class III. Firm initiated recall ongoing. Firm notified users by letter in May 2011. Volume in Commerce: 21,825 units. Reason: The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or “lead off” indications. FDA recall #Z-2625-2011. FDA Enforcement Report, 8/3/11.

SPACELABS HEALTHCARE LLC., Issaquah, WA. Manufacturer: Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom. Pathfinder Holter Analyzer. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 3rd, 2011. Volume in Commerce: 58 units (5 in US). Reason: A potential hazard associated with the use of the software. The second 24 hours of a 48 hours EVO recording will not be analyzed. FDA recall #Z-2611-2011. FDA Enforcement Report, 8/3/11.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Arbor, MI. CDI TM 101 Hematocrit / Oxygen Saturation Monitoring System. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 28th, 2011. Volume in Commerce: 622 units. Reason: The presence of electromagnetic interference (EMI) in the OR may affect the accuracy values displayed. FDA recall #Z-2610-2011. FDA Enforcement Report, 8/3/11.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Harbor, MI. System 1 Base and Large Roller Pump 6” Diameter. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 21st, 2011. Volume in Commerce: 3,679 units. Reason: The firm has received multiple reports of the lower pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. FDA recall #Z-2735/2738-2011. FDA Enforcement Report, 8/10/11.

WAVELIGHT AG., Pressath, Germany. Wavelight FS200 Femtosecond Laser System. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 18th, 2011. Volume in Commerce: 55 units. Reason: The software calculating the patterns were found to have a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue. FDA recall #Z-2292-2011. FDA Enforcement Report, 8/3/11.