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September 2012 - vol. 21:09

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.

CLASS I RECALL: GE OEC MEDICAL SYSTEMS, Inc., Salt Lake City, UT. OEC IT3000, IT2500, IT2500 Plus, IT3500 & IT3500 Plus, ConneCTstat, ConneCTstat Plus. Firm initiated recall completed. Firm notified users by letter on June 22nd, 2009. Volume in Commerce: 768 units. Reason: GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment. FDA recall #Z-2251-2012 FDA Enforcement Report, 9/5/12.

CLASS I RECALL: I-FLOW CORPORATION Lake Forest, CA. ON-Q pump with ONDEMAND Bolus Button. Firm initiated recall ongoing. Firm notified users by letter on May 8th, 2012. Volume in Commerce: 65,926 units in the US. Reason: It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected. FDA recall #Z-2253-2012. FDA Enforcement Report, 9/5/12.

CLASS I RECALL: RESPIRONICS CALIFORNIA INC., Carlsbad, CA. V60 Ventilator, Continuous Ventilator, Model #V60. Firm initiated recall ongoing. Firm notified users by letter on July 31st, 2012. Volume in Commerce: 116 units in the US. Reason: Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation. FDA recall #Z-2260-2012. FDA Enforcement Report, 9/12/12.

CLASS I RECALL: NEWPORT MEDICAL INSTRUMENTS INC., Costa Mesa, CA. Newport HT70 and HT70 Plus Ventilators. Firm initiated recall ongoing. Firm notified users by letter on August 3rd, 2012. Volume in Commerce: 72 units. Reason: Due to a component failure on the control board unit may emit a continuous high priority alarm and the ventilator may stop ventilating. FDA recall #Z-2250-2012. FDA Enforcement Report, 9/12/12.

COVIDIEN LLC., Sunnyvale, CA. HALO Flex Energy Generators. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 3rd, 2012. Volume in Commerce: 617 generators. Reason: Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care. FDA recall #Z-2379-2012. FDA Enforcement Report, 9/26/12.

MINDRAY DS USA, INC. D.B.A. MINDRAY NORTH AMERICA, Mahwah, NJ. V Series Patient Monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 7th, 2012. Volume in Commerce: 979 units. Reason: Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012. FDA recall #Z-2279-2012. FDA Enforcement Report, 9/5/12.

NELLCOR PURITAN BENNETT INC., Boulder, CO. DGPHP RFA High-Power Single Use Grounding Pads & Cool-Tip RFA Electrode Kits. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 1st, 2012. Volume in Commerce: 184,934 units. Reason: Covidien is conducting a recall of various production lots of DGPHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGPHP single use grounding pad which may result in an electrical burn to the patient at the application site. FDA recall #Z-2301-2012. FDA Enforcement Report, 9/5/12.

PHILIPS HEALTHCARE INC., Andover, MA. Philips SureSigns VSi/VS2+ Patient Monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 15th, 2012. Volume in Commerce: 2,314 units. Reason: Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount. FDA recall #Z-2303-2012. FDA Enforcement Report, 9/5/12.

PHILIPS HEALTHCARE INC., Andover, MA. Philips HeartStart MRx monitor / defibrillators.. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 20th, 2012. Volume in Commerce: 58,701 units. Reason: Therapy cable connection wear may lead to a malfunction in detection of defibrillation pads / paddles therapy cables. FDA recall #Z-2347-2012. FDA Enforcement Report, 9/19/12.

PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC., Cleveland, OH. MX 16-slice CT Scanner System. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 24th, 2012. Volume in Commerce: 328 units. Reason: On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. FDA recall #Z-2386-2012. FDA Enforcement Report, 9/26/12.

SIEMENS MEDICAL SOLUTIONS USA INC., Malvern, PA. Syngo Imaging XS. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 18th, 2012. Volume in Commerce: 52 units. Reason: There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms". FDA recall #Z-2264-2012. FDA Enforcement Report, 9/5/12.

SPACELABS HEALTHCARE LLC., Issaquah, WA. Ultraview SL 91493 Integrated Module Housing. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 27th, 2012. Volume in Commerce: 350 units in the US. Reason: There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing. FDA recall #Z-2382-2012. FDA Enforcement Report, 9/26/12.

STERIS CORPORATION, Mentor, OH. Quick Connect Device. Class II. Firm initiated recall ongoing. Firm notified users by a visit on August 10th, 2012. Volume in Commerce: 64 units. Reason: STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field. FDA recall #Z-2284-2012. FDA Enforcement Report, 9/5/12.

STERIS CORPORATION, Mentor, OH. SYSTEM 1E Liquid Sterilant Processing System. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 1st, 2012. Volume in Commerce: 6,051 units. Reason: The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property. FDA recall #Z-2346-2012. FDA Enforcement Report, 9/19/12.

STERIS CORPORATION, Mentor, OH. STERIS 5085 and 5085 SRT Surgical Tables. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 6th, 2012. Volume in Commerce: 379 units. Reason: STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlocked when in fact the floor locks are engaged. FDA recall #Z-2426-2012. FDA Enforcement Report, 9/26/12.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC., Tustin, CA. Toshiba CT Systems. Class II. Firm initiated recall completed. Firm notified users by letter on Feb 27th, 2008. Volume in Commerce: 757 units. Reason: The systems all have a similar table control board. It has been found that this board may cause the table position to be incorrect if the table cradle is moved manually. This is referred to as "Free" mode in the operation manuals. If this error does occur it is possible that the patient could be scanned at an incorrect position. FDA recall #Z-2266-2012. FDA Enforcement Report, 9/5/12.

TRUMPF MEDICAL SYSTEMS, INC., Charleston, SC. Acrobat 3000 Spring Arm Support for iLED operating lights. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 29th, 2012. Volume in Commerce: 402 units. Reason: Cracks can arise on the welded seam on the rear joint. FDA recall #Z-2311-2012. FDA Enforcement Report, 9/12/12.

VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS, Palo Alto, CA. Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 14th, 2012. Volume in Commerce: N/A. Reason: Some X-jaws (lower collimator jaw) carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. If both jaw carriers on the same X-jaw were to crack, the jaw would be able to move freely in the closed direction. In this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry; Treatment after such a failure occurs may lead to an under-dose of the intended target volume. This condition was found on some machines. FDA recall #Z-2383-2012. FDA Enforcement Report, 9/26/12.