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Around the MBI Circuit

Modern Biomedical

February 2012 - vol. 21:02

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 MEDWATCH – CLASS I RECALL: Salter Labs. 7600 Bubble Humidifier. FDA notified healthcare professionals of a class I recall due to the 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. RECOMMENDATION: Salter Labs contacted its direct consumers on October 21, 2011, to inform them of the recall. Salter Labs instructed consumers who have the affected bubble humidifiers to examine its inventory of the recalled product and remove and quarantine all affected products. FDA posted 2/14/12.

FDA MEDWATCH – CLASS I RECALL: Smiths Medical. Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes. FDA notified healthcare professionals of a class I recall of certain lots of these tracheostomy tubes. Difficulty arising from disconnecting accessories from the connectors of the affected tubes may result in excessive force to detach the accessory and the tracheostomy tube may dislodge from the patient. This could lead to serious injury or death, especially if no replacement tube is immediately available. RECOMMENDATION: Consumers who have the affected tubes should identify all affected, unused product in inventory and segregate it to a quarantine location. Contact Smiths Medical Customer Service at 1-800-258-5361. Smiths Medical mailed an Urgent Field Safety Notice on November 28th, 2011 and an updated Urgent Field Safety Notice on January 9th, 2012.

CLASS I RECALL: NEMSCHOFF, Sheboygan, WI. Perinatal Bassinet. Firm initiated recall ongoing. Firm notified users by letter and e-mail on October 14th, 2011. Volume in Commerce: 1,214 units. 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. FDA recall #Z-0832-2012. FDA Enforcement Report, 2/15/12.

ALLEN MEDICAL SYSTEMS, INC., Acton, MA. Allen C-Flex Head Postioning System. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 18th, 2011. Volume in Commerce: 83 units. Reason: C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity. FDA recall #Z-0655-2012. FDA Enforcement Report. 2/22/12.

BECKMAN COULTER INC., Brea, CA. Manufacturer: Beckman Coulter Kk, Sunto-gun, Japan. AU Clinical Chemistry Analyzers. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 27th, 2011. Volume in Commerce: 8,225 units. Reason: The AU Clinical Chemistry Analyzers may experience cuvette overflow. FDA recall #Z-0974/0977-2012. FDA Enforcement Report, 2/22/12.

BIO-DETEK, INC., Pawtucket, RI. Zoll pedi.padz Reduced Energy Multi Function Electrodes. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 30th, 2011. Volume in Commerce: 3,080 units. Reason: Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter. FDA recall #Z-1011-2012. FDA Enforcement Report, 2/22/12.

CAREFUSION 303, INC., San Diego, CA. Alaris PC unit model 8015. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 13th, 2011. Volume in Commerce: 1,039 units. 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. FDA recall #Z-0876-2012. FDA Enforcement Report, 2/15/12.

GE HEALTHCARE, LLC., Waukesha, WI. Manufacturer: GE Ultrasound Korea Co., Ltd., Kyunggi-Do Korea. GE Logiq P6 Ultrasound System. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 23rd, 2011. Volume in Commerce: 2,270 units. Reason: GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators. FDA recall #Z-0834-2012. FDA Enforcement Report, 2/1/12.

INVACARE CORP., Elyria, OH. Manufacturer: Chien Ti Enterprise Co., Hsin Chuang, Taipei, Taiwan. Leo 3-Wheel Scooter. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 7th, 2011. Volume in Commerce: 391 scooters. 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. FDA recall #Z-0774-2012. FDA Enforcement Report, 2/1/12.

LEICA MICROSYSTEMS INC., Buffalor Grove, IL. Manufacturer: Leica Microsystems (Schweiz) Ag, Heerbrugg, Switzerland. Leica M822 Surgical Microscope. Class II. Firm initiated recall ongoing. Firm notified users by e-mail on December 21st, 2011. Volume in Commerce: 29 units. Reason: Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use. FDA recall #Z-1042-2012. FDA Enforcement Report. 2/22/12.

LIFE RECOVERY SYSTEMS HD, LLC., Waldwick, NJ. Manufacturer: Nexcore Technology, Inc., Waldwick, NJ. ThermoSuit. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 24th, 2011. Volume in Commerce: 28 units. Reason: ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading. FDA recall #Z-0456-2012. FDA Enforcement Report, 2/22/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Gemini TF 16 PET/CT System. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 5th, 2011. Volume in Commerce: 197 units. 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. FDA recall #Z-0805-2012. FDA Enforcement Report, 2/15/12.

PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC., Cleveland, OH. Gamma Camera Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 15th, 2011. Volume in Commerce: 795 units. 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. FDA recall #Z-0988-2012. FDA Enforcement Report. 2/22/12.

SIEMENS MEDICAL SOLUTIONS USA INC., Malvern, PA. Manufacturer: Siemns AG, Medical Soultions, Business Unit XP. Erlangen, Germany. Siemens MAGNETOM Aera/Skyra. Class II. Firm initiated recall ongoing. Firm notified users by telephone on November 24th, 2010. Volume in Commerce: 128 units. 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. FDA recall #Z-0940-2012. FDA Enforcement Report, 2/15/12.

STERIS CORPORATION HOPKINS FACILITY Mentor, OH. Steris System 1E Liquid Chemical Sterilant Processing System. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 8th, 2011. Volume in Commerce: 3,882 units. 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. FDA recall #Z-0869-2012. FDA Enforcement Report, 2/8/12.

STRYKER COMMUNICATIONS CORP., Flower Mound, TX. Visum LED Surgical Lights. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 7th, 2011. Volume in Commerce: 1,143 devices. 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. FDA recall #Z-0913-2012. FDA Enforcement Report, 2/1/12.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Harbor, MI. Terumo, Sarns Sternal Saw I System. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 16th, 2011. Volume in Commerce: 10,187 units. 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. FDA recall #Z-0978-2012. FDA Enforcement Report. 2/22/12.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC. Tustin, CA. DRAD 3000E X Ray System. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 29th, 2011. Volume in Commerce: 39 units. Reason: It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable. FDA recall #Z-0941-2012. FDA Enforcement Report, 2/8/12.


TRUMPF MEDICAL SYSTEMS, INC., Charleston, SC. Manufacturer: Kreuzer Gmbh & Co. KG, Puchheim, Germany. Surgical lighting systems iLED and TruLight. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 9th, 2012. Volume in Commerce: 8,733 units (4,709 US). Reason: The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient. FDA recall #Z-1010-2012. FDA Enforcement Report. 2/15/12.