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QUARTERLY SUMMARY: January – March 2012

A summary of FDA recalls, safety alerts, and manufacturer field corrective actions as reported for the first quarter of the year. This information is a snapshot and chronology of the reported events. For additional details refer to the cited volume of original publication or contact the Home Office.

ADVANCED STERILIZATION PRODUCTS, Irvine, CA. STERRARD 200 Sterilizer. Class II. Reason: ASP determined that an internal filter in the vacuum pump on the STERRARD 200 System is subject to wear over time. Vol. 21:03.

AGFA CORP., Greenville, SC. Agfa Computed Radiography Systems with DX-G Digitizer. Class II. Reason: Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during start up or during a cassette scan cycle. Vol. 21:01.

ALLEN MEDICAL SYSTEMS, INC., Acton, MA. Allen C-Flex Head Postioning System. Class II. Reason: C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity. Vol. 21:02.

B. BRAUN MEDICAL INC., Allentown, PA. Infusomat Space Pump.Class I. Reason: Potential for breakage of 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. If the clip catch is broken and the door opened, free flow protection is still ensured. Vol. 21:03.

BECKMAN COULTER INC., Brea, CA. Coulter Hematology Analyzer. Class II. Reason: Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. Vol. 21:01

BECKMAN COULTER INC., Brea, CA. AU Clinical Chemistry Analyzers. Class II. Reason: The AU Clinical Chemistry Analyzers may experience cuvette overflow. Vol. 21:02.

BIO-DETEK, INC., Pawtucket, RI. Zoll pedi.padz Reduced Energy Multi Function Electrodes. Class II. Reason: Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter. Vol. 21:02.

CAREFUSION 211 INC., Yorba Linda, CA. .AVEA Ventilator. Class I. Reason: The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilator and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Vol. 21:01.

CAREFUSION 303, INC., San Diego, CA. Alaris PC unit model 8015. Class II. Reason: Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely. Vol. 21:02.

CARL ZEISS INC., Thornwood, NY. Microimaging Laser – TIRF and DirectFRAP Imaging System. Class II. Reason: The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to prevent unintended exposure to Class 3B laser radiation. Vol. 21:03.

FLIGHT MEDICAL LTD., Lod, Israel. V24-00400-29 Cable to the Newport HT50 Ventilator. Class II. Reason: A problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off. Vol. 21:03

GE HEALTHCARE, LLC., Waukesha, WI. GE Logiq E9 Diagnostic Ultrasound Systems. Class II. Reason: User may notice an image from a different patient, or an image from the current patient with title information from a different patient or incorrect measurements / calculations on images when viewed on the off-line review station. As a result imaging may need to be repeated due to the confusion in the image information. Vol. 21:01.

GE HEALTHCARE, LLC., Waukesha, WI. GE Logiq P6 Ultrasound System. Class II. Reason: GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators. Vol. 21:02.

GE HEALTHCARE, LLC, Waukesha, WI. GE Discovery NM/CT 670 and NM 630. Class II. Reason: The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. Another issue is that the lead cover handle separation could result in plate swing resulting in potential injury to service personnel. Vol. 21:03.

INO THERAPEUTICS, Madison, WI. INOmax DS (Delivery System) Model 10003 & 10007. Class I. Reason: Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR 806.10. Vol. 21:01.

INTERSURGICAL INC., Liverpool, NY. IS Can Disposable CO2 absorber x 6 on GE rebreathing systems. Class II. Reason: Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system. Vol. 21:01.

INVACARE CORP., Elyria, OH. Leo 3-Wheel Scooter. Class II. Reason: The scooter backrest fails unexpectedly due to seat flexing and this has the potential to result in a person falling causing death or serious injury. Vol. 21:02.

LEICA MICROSYSTEMS INC., Buffalor Grove, IL. Leica M822 Surgical Microscope. Class II. Reason: Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use. Vol. 21:02.

LIFE RECOVERY SYSTEMS HD, LLC., Waldwick, NJ. ThermoSuit. Class II. Reason: ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading. Vol. 21:02.

LINET AMERICAS, INC. Charlotte, NC. Linet Remote Handset for Multicare Eleganza 3 and Eleganza Smart hospital beds. Class II. Reason: The premature failure of the Remote Handset buttons may result in unintended movement of the bed. Vol. 21:03.

MAQUET CARDIOVASCULAR US SALES, LLC., Wayne. NJ. Maquet Quadrox iD Pediatric Oxygenator. Class II. Reason: There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oxygenator. Vol. 21:01.

MIDMARK CORP., Versailles, OH.. M11 Ultra Steam Sterilizer. Class II. Reason: During a FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. Vol. 21:01.

MINDRAY DS USA, INC., V Series Monitor. Class II. Reason: A system database corruption may occur that causes the V Series Monitor to reset. Vol. 21:03.

NEMSCHOFF, Sheboygan, WI. Perinatal Bassinet. Class I. Reason: To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits. Vol. 21:02.

OLYMPUS AMERICA INC., Center Valley, PA. Olympus Electrosurgical Unit. Class II. Reason: Investigations of customers complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100. Vol. 21:01.

OLYMPUS AMERICA INC. Center Valley, PA. Olympus Endoscopic Electrosurgical Unit. Class II. Reason: Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements. Vol. 21:03.

PHILIPS HEALTHCARE INC., Andover, MA. Philips IntelliVue Patient Monitors. Class II. Reason: Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor. Vol. 21:03.

PHILIPS MEDICAL SYSTEMS, San Jose, CA. Extended Brilliance Workstation. Class II. Reason: A problem related to a software error has been detected. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur. Vol. 21:01.

PHILIPS MEDICAL SYSTEMS, San Jose, CA. SKYlight Imaging Systems, Model 882050. Class II. Reason: During preventive maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner. Vol. 21:01.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Gemini TF 16 PET/CT System. Class II. Reason: Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are reconstructed. Vol. 21:02.

PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC., Cleveland, OH. Gamma Camera Systems. Class II. Reason: Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling. Vol. 21:02.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance CT System (Big Bore, 64 CT, and Ingenuity). Class II. Reason: Software errors. A number of non-conformances were logged during in house testing and external validation testing equipped with software version 3.5 Beta 2. Vol. 21:03.

RESPIRONICS, INC., Trilogy 100 Ventilators. Class I. Reason: A manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient. Vol. 21:01

SALTER LABS, 7600 Bubble Humidifier. Class I. Reason: Humidifier lids failed to pop off at the intended pressure. When the pop off occurs, the brass slug does not always reseat to the appropriate position. When the slug fails to reseat properly, the humidifier can leak. A leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop resulting in death or serious adverse health consequences. Vol. 21:02.

SIEMENS MEDICAL SOLUTIONS USA INC., Malvern, PA. Siemens MAGNETOM Aera/Skyra. Class II. Reason: During product monitoring firm has discovered that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, leading to the emission of smoke and possible material damage requiring service. Vol. 21:02.

SIEMENS MEDICAL SOLUTIONS USA INC., Malvern, PA. Siemens syngo Imaging XS. Class II. Reason: Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images / series from the Patient Browser using the thumbnails may cause unintended deletion of images / series. Vol. 21:03.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Linear Accelerators with RT Therpaist Workspace, version 4.1 Class II. Reason: Software upgrade to installed base to the lateset release of the RT Therpaist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment. Vol. 21:03.

SMITHS MEDICAL, Rockland, MA., HOTLINE Disposable Administration Sets. Class II. Reason: Disconnected / loose Luer connectors at the patient end of the triple lumen tubing of the HOTLINE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets. Vol. 21:01.

SMITHS MEDICAL. Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes. Class I. Reason: Certain lots of these tracheotomy tubes. Difficulty arising from disconnecting accessories from the connectors of the affected tubes may result in excessive force to detach the accessory and the tracheotomy tube may dislodge from the patient. This could lead to serious injury or death, especially if no replacement tube is immediately available. Vol. 21:02.

STERIS CORPORATION HOPKINS FACILITY Mentor, OH. Steris System 1E Liquid Chemical Sterilant Processing System. Class II. Reason: Software deficiency. Steris identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteria may lead to aborts by the System 1E Processing System. Vol. 21:02.

STRYKER COMMUNICATIONS CORP., Flower Mound, TX. Visum LED Surgical Lights. Class II. Reason: Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm, it could lead to serious injury. Vol. 21:02.

SYNTHES USA INC., West Chester, PA. Synthes Oscillating Saw Attachment for Small Battery Drive. Class II. Reason: The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and or user. Vol. 21:01.

TENET MEDICAL ENGINEERING, Calgary, Canada. Smith & Nephew, SPIDER2 Limb Postitioner. Class II. Reason: SPIDER2 may unlock (loss of traction) resulting in potential movement of the patient when the device is within close proximity to an RF source. Loss of traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage. Vol. 21:01.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Arbor, MI. CDI 101 Hematocrit / Oxygen Saturation Monitoring System. Class II. Reason: Terumo has not submitted a 510(k) to FDA to market the device. Vol. 21:01.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Harbor, MI. Terumo, Sarns Sternal Saw I System. Class II. Reason: Terumo has received one report of minute metal shavings leaking from the Sarns Sternal Saw I system at the point where the saw blade is inserted into the saw handpiece. Vol. 21:02.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC. Tustin, CA. DRAD 3000E X Ray System. Class II. Reason: It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable. Vol. 21:02.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC., Tustin, CA. TSX-301A and 301B AQUILION ONE System. Class II. Reason: The recall was initiated because Toshiba has confirmed that there is a potential software issue for the TSX-301A and 301B. Vol. 21:03.

VARIAN MEDICAL SYSTEMS, INC. Palo Alto, CA. Varian Linear Accelerators. Class II. Reason: Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient, in both the manual mode and the automatic mode. Vol. 21:01.

VARIAN MEDICAL SYSTEMS, INC. Palo Alto, CA. Varian brand ARIA Radiation Oncology. Class II. Reason: The Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation. Vol. 21:03.