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November 2012 - vol. 21:11

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: HEARTSINE TECHNOLOGIES, LIMITED, Belfast, GB. HeartSine Samaritan 300/300P PAD devices. Firm initiated recall ongoing. Firm notified users by letter on September 13th, 2012. Volume in Commerce: 81,982 units. Reason: Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted from the device. If the device does not detect that the audible prompts are followed (e.g., a patient is connected to the electrodes to allow the device to read the patient's ECG and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power. Issue 2 (Battery Management Software Issue): Certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery. This issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains. This may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock. If the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device may not deliver any shocks, or it may only deliver one shock before turning itself off. There is more information on the FDA website. FDA recall #Z-0124-2013. FDA Enforcement Report, 11/7/12.

CLASS I RECALL: MINRAY DS USA INC., DBA MINDRAY NORTH AMERICA, Mahwah, NJ. Mindray A3 and A5 Anesthesia Delivery System. Firm initiated recall ongoing. Firm notified users by letter on August 13th, 2012. Volume in Commerce: 372 units. Reason: Mindray has identified the potential for a system leak resulting in an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case. FDA recall #Z-0290/0291-2013. FDA Enforcement Report, 11/28/12.

CLASS I RECALL: VENTLAB CORPORATION, Mocksville, NC. Safe Spot Infant Resuscitator. Firm initiated recall ongoing. Firm notified users by letter on July 11th, 2012. Volume in Commerce: 14,602 units. Reason: Possible volume leakage through the inlet valve during compressions of the resuscitator bag. There is more information and complete listing of models on the FDA website. FDA recall #Z-0170/0181-2013. FDA Enforcement Report, 11/7/12.

ELEKTA, INC., Norcross, GA. MOSAIQ (EMR) used for oncology workflow management. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 18th, 2012. Volume in Commerce: 300 units. Reason: A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. FDA recall #Z-0169-2013. FDA Enforcement Report, 11/7/12.

GE HEALTHCARE, LLC., Waukesha, WI. GE Healthcare Optima XR 200amx. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 20th, 2012. Volume in Commerce: 364 units. Reason: It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. FDA recall #Z-0197/0200-2013. FDA Enforcement Report, 11/28/12.

MAQUET CARDIOVASCULAR US SALES, LLC, Wayne, NJ. QUADROX Diffusion Membrane Oxygenator. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 12th, 2012. Volume in Commerce: 23,203 units. Reason: It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. FDA recall #Z-0160-2013. FDA Enforcement Report, 11/7/12.

MOOG MEDICAL DEVICES GROUP, Salt Lake City, UT. EnteraLite Infinity Feeding Pump. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 8th, 2012. Volume in Commerce: 8,736 units. Reason: MOOG Medical Devices Group is conducting a voluntary recall for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps. Certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pumps, resulting in an error 13 message and shutting the pump down entirely. FDA recall #Z-0294-2013. FDA Enforcement Report, 11/21/12.

PRIMUS MEDICAL LLC., Boardman, OH. AC Powered adjustable hospital bed. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 2nd, 2011. Volume in Commerce: 342 beds. Reason: The Retaining washers & Clevis Pins provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse. FDA recall #Z-0270-2013. FDA Enforcement Report, 11/14/12.

SHIMADZU MEDICAL SYSTEMS, Torrance, CA. Diagnostic X-Ray Beam Limiting Device. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 28th, 2011. Volume in Commerce: 1,402 units. Reason: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements in some x-ray generating conditions after the revision in 2006. FDA recall #Z-0260/0265-2013. FDA Enforcement Report, 11/14/12.

SPACELABS HEALTHCARE, LLC. Issaquah, WA. XPREZZON bedside monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 5th, 2012. Volume in Commerce: 98 in US. Reason: Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. FDA recall #Z-0196-2013. FDA Enforcement Report, 11/14/12.

SPACELABS HEALTHCARE, LLC. Issaquah, WA. qube Compact Patient Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 19th, 2012. Volume in Commerce: 530 in US. Reason: Spacelabs Healthcare has learned through several reports that the input circuit may fail and the monitor will go on battery mode. The monitor will function normally until the batteries become depleted and then the monitor will shut down. In addition the monitor may fail to turn on due to an internal short. FDA recall #Z-0403-2013. FDA Enforcement Report, 11/28/12.

STRYKER SPINE, Allendale, NJ. Aviator Drill Bit. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 5th, 2012. Volume in Commerce: 6,154 units. Reason: Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm. FDA recall #Z-0163-2013. FDA Enforcement Report, 11/7/12.

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, Ann Arbor, MI. Perfusion System 8000. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 25th, 2012. Volume in Commerce: 2,256 units. Reason: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. FDA recall #Z-0280/0285-2013. FDA Enforcement Report, 11/21/12.

VITAL SIGNS COLORADO, INC., Englewood, CO. Vital Signs Disposable General Purpose 9 French Temperature Probe. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 17th, 2012. Volume in Commerce: 243,685 units. Reason: There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe. FDA recall #Z-0407-2013. FDA Enforcement Report,11/28/12.

ZIMMER, INC., Warsaw, IN. ATS 3000 Automatic Tourniquet System. Class II. Firm initiated recall ongoing. Firm notified users by 2 of the following; fax, e-mail, press release, phone, or letter on September 5th, 2012. Volume in Commerce: 204 units. Reason: Zimmer is conducting a voluntary removal of some Zimmer ATS 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the control board. FDA recall #Z-0296-2013. FDA Enforcement Report,11/21/12.