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July 2012 - vol. 21:07

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: BBraun Medical, Inc., Allentown, PA. Infusomat(R) Space Pump (US version). Firm initiated recall ongoing. Firm notified users by letter on March 23rd, 2012. Volume in Commerce: 38,225 pumps. Reason: Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. FDA recall #Z-1992-2012. FDA Enforcement Report, 7/25/12.

CLASS I RECALL: CareFusion 203 Inc., Minneapolis, MN. EnVe Ventilator. Firm initiated recall ongoing. Firm notified users by letter on June 19th, 2012. Volume in Commerce: 266 units. Reason: CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a low PEEP or Patient Circuit Fault Alarm both audibly and visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised. FDA recall #Z-2006-2012. FDA Enforcement Report, 7/25/12.

CLASS I RECALL: CareFusion 2200 Inc., McGaw Park, IL. Airlife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated. Firm initiated recall ongoing. Firm notified users by letter on May 29th, 2012. Volume in Commerce: N/A. Reason: The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. FDA recall #Z-1899/1901-2012. FDA Enforcement Report, 7/11/12.

CLASS I RECALL: Maquet Cardiovascular US Sales LLC, Wayne, NJ. FLOW-I Anesthesia System. Firm initiated recall ongoing. Firm notified users by letter on February 20th, 2012. Volume in Commerce: 284 units. Reason: A technical alarm may be generated on the FLOW-I system when using the MAN / AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the “on” or “off” position but remains in the “in-between position.” FDA recall #Z-1925-2012. FDA Enforcement Report, 7/18/12.

DRAEGER MEDICAL SYSTEMS, INC., Telford, PA. Drager PT 4000 Phototherapy System. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 2nd, 2012. Volume in Commerce: 65 units. Reason: A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. FDA recall #Z-1950-2012. FDA Enforcement Report, 7/18/12.

GE HEALTHCARE, LLC., Waukesha, WI. Optima Mobile X-Ray System. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 4th, 2012. Volume in Commerce: 254 units. Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product. FDA recall #Z-1993-2012. FDA Enforcement Report, 7/25/12.

GE HEALTHCARE, LLC., Waukesha, WI. Invasive Blood Pressure Care Cables. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 12th, 2012. Volume in Commerce: 279 units. Reason: There is a potential safety issue with its Invasive Blood Pressure Cable made for use with Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly. FDA recall #Z-2015-2012. FDA Enforcement Report, 7/25/12.

GE OEC MEDICAL SYSTEMS, INC., Salt Lake City, UT. OEC 9900 Elite, OEC 9800, OEC 8800 Motorized C-Arm System. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 19th, 2007. Volume in Commerce: 13,175 units. Reason: FDA inspection identified that the vertical lift column power supply in the mainframe C-Arm is defective and subject to early life failure. FDA recall #Z-2025/2027-2012. FDA Enforcement Report, 7/25/12.

GE OEC MEDICAL SYSTEMS, INC., Salt Lake City, UT. OEC Uroview 2800, Model A349855. Class II. Firm initiated recall terminated. Firm notified users by letter initially on November 20th, 2006. Volume in Commerce: 717 units. Reason: Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in “film mode” and “digital spot mode”, and the system does not reboot. FDA recall #Z-1865-2012. FDA Enforcement Report, 7/5/12.

GULF FIBEROPTICS, INC., Oldsmar, FL. Replacement Surgical Headlight Cable for Cogent Microlink. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 9th, 2012. Volume in Commerce: 169 units. Reason: The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm’s 510K due to light transmitting fiber material difference. FDA recall #Z-2029-2012. FDA Enforcement Report, 7/25/12.

HILL-ROM, INC., Batesville, IN. Advanta 2 Bed. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 18th, 2012. Volume in Commerce: 7,843 devices. Reason: During an evaluation of Advanta 2 side rail samples returned from the field, it was found that the screws used to attach the side rail were being stripped from the plastic cavity of the side rail. FDA recall #Z-1864-2012. FDA Enforcement Report, 7/5/12.

HITACHI MEDICAL SYSTEMS AMERICA INC., Twinsburg, OH. Hitachi Scenaria CT System Software. Class II. Firm initiated recall ongoing. Firm notified users by two or more by e-mail, fax, letter, press release telephone or visit on May 4th, 2012. Volume in Commerce: 6 units. Reason: A software error was discovered in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. FDA recall #Z-2037-2012. FDA Enforcement Report, 7/25/12.

INVACARE CORPORATION, Elyria, OH. TDX SP Power Wheelchair. Class II. Form initiated recall ongoing. Firm notified users by letter on April 6th, 2012. Volume in Commerce: 655 chairs. Reason: Potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse. FDA recall #Z-1905-2012. FDA Enforcement Report, 7/11/12.

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: 2,914 units. Reason: HeartStart MRx had unexpected pads / paddles ECG failure. FDA recall #Z-1896-2012. FDA Enforcement Report, 7/5/12.

PHILIPS HEALTHCARE INC., Andover, MA. Philips Heartstart MRx M3536A Defibrillator / Monitor with Software R.03.03. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 20th, 2012. Volume in Commerce: 35 units. Reason: Defib / monitor cannot analyze an ECG report during acquisition of 12 lead ECG. FDA recall #Z-1986-2012. FDA Enforcement Report, 7/18/12.

SMITHS MEDICAL ASD INC., Rockland, MA. HOTLINE 3 Blood and Fluid Warmer. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 27th, 2012. Volume in Commerce: 2,247 units. Reason: If the HOTLINE 3 Blood and Fluid Warmer disposable is not correctly installed, the microswitch may become damaged and unusable. FDA recall #Z-1979-2012. FDA Enforcement Report, 7/18/12.

SPACELABS HEALTHCARE, LLC., Issaquah, WA. Spacelabs Medical Xprezzon Bedside Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 12th, 2012. Volume in Commerce: 21 units. Reason: There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor. FDA recall #Z-2019-2012. FDA Enforcement Report, 7/25/12.

STRYKER ENDOSCOPY, San Jose, CA. Formula Shaver Handpiece (with buttons). Class II. Firm initiated recall ongoing. Firm notified users by letter on May 21st, 2012. Volume in Commerce: 34 devices. Reason: Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control. FDA recall #Z-1866-2012. FDA Enforcement Report, 7/5/12.

TELEFLEX MEDICAL, Research Triangle Park, NC. Hudson RCI Concha Therm Neptune Humidifier. Class II. Firm initiated recall is completed. Firm notified users by letter on June 12th, 2012. Volume in Commerce: 14,794 each. Reason: Speaker failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment. FDA recall #Z-2036-2012. FDA Enforcement Report, 7/25/12.

VITAL SIGNS DEVICES, a GE Healthcare Company, Totowa, NJ. enFlow IV Fluid Warmer. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 20th, 2012. Volume in Commerce: 11,803 cases. Reason: The enFlow Warmer strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours. FDA recall #Z-1972-2012. FDA Enforcement Report, 7/18/12.