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Modern Biomedical

“Modern has the ability to understand and fulfill our clients needs while meeting and exceeding their expectations. A customers expectation of equipment readiness is met through combining a quick response with technical expertise to achieve minimal downtime and effective cost containment. In a nutshell, solving problems is what we do. Our clients are able to relax and focus their efforts elsewhere”
– Randy Bullard, President/CEO

December 2011 - vol. 20:15

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 Med Watch

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation Class I. FDA notified healthcare professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death. The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions. The recalled ventilators were manufactured between March 1, 2009 and June 30, 2011. RECOMMENDATION: CareFusion's Recall Support Center is contacting customers to arrange for onsite remediation of the affected devices. Customers were instructed to follow these steps if any AVEA ventilator in their facility exhibits a sustained extended high peak alarm followed by the opening of the safety valve: 1. Remove the ventilator from service. 2. Provide alternate ventilation. 3. Contact CareFusion Technical Support at 1-800-231-2466 to report the issue. FDA posted 12/23/11.

FDA MedWatch -ShoulderFlex Massager: Warning - Risk of Strangulation Class I: FDA is warning consumers not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks. Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. There have been reports of one death and one near death, due to strangulation, associated with the use of this device. King International recalled the ShoulderFlex Massager on Aug. 31, 2011; however, during a recent compliance audit, the FDA found that the company has gone out of business. King International has not followed through with recall procedures; the 800 number established by the firm for this recall is no longer in service; and many of the companies that sell this device are not aware of the recall or did not properly notify customers who purchased the massager. Estimated product in commerce: 11,934 units. RECOMMENDATIONS: Consumers should stop using this device. The FDA recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers should be removed and disposed of separately from the device; the power supply should be disposed of separately, as well. FDA MedWatch 12/21/11. FDA Enforcement Report, 12/21/11.

AMO Manufacturing USA, LLC, Milpitas, CA. Abbott brand IntraLase Femtosecond Laser System. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 12th, 2011. Volume in Commerce: 1,226 Total Laser Systems. Reason: The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System. FDA recall #Z-0165/0167-2012. FDA Enforcement Report, 12/7/11.

ATOM MEDICAL CORP., Bunkyo-Ku, Japan. Dual Incu i (Atom Infant Incubator): Models 100, 101, 102, and 103. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 18th, 2011. Volume in Commerce: 453 units. Reason: The caster with lock on the radiant-warming open type incubator may become loose or break. FDA recall #Z-0337/0340-2012. FDA Enforcement Report, 12/28/11.

CINCINNATI SUB ZERO PRODUCTS INC., Cincinnati, OH. Steri–Probe Temperature Probe, Esophageal / Rectal Probe. Class II. Firm initiated recall ongoing. Firm notified users by telephone on November 1st, 2011. Volume in Commerce: 369,680 Reason: Reports that the Rectal / Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a ‘check probe’ error. FDA recall #Z-0372-2012. FDA Enforcement Report, 12/21/11.

DRAEGER MEDICAL INC., Telford, PA. Draeger Infinity Delta, Delta XL, Gamma XXL and Kappa Monitors. Class II. Firm initiated recall ongoing. Firm notified users by telephone on October 25th, 2011. Volume in Commerce: 14,894 units. Reason: Complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Massimo SET pod is used for SpO2 measurements. FDA recall #Z-0281-2012. FDA Enforcement Report, 12/7/11.

INTEGRA LIFESCIENCES CORP., Plainsboro, NJ. Manufacturer: Integra, Burlington MA, Inc., Burlington MA. Integra Surgical Luxtec Light Source. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 14th, 2011. Volume in Commerce: 97 units. Reason: A loose screw may result in shifting of components and improper function of the turret or actuator assembly. FDA recall #Z-0356/0358-2012. FDA Enforcement Report. 12/14/11.

INTEGRA LIFESCIENCES CORP., Plainsboro, NJ. Manufacturer: Integra, Burlington MA, Inc., Burlington MA. Luxtex Headlight System. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 10th, 2011, via FedEx, email or telephone. Volume in Commerce: Unknown Reason: Headlight assembly (module) may become loose and separate from the headband assembly. FDA recall #Z-0373/0381-2012. FDA Enforcement Report. 12/14/11.

INVACARE CORP., Elyria, OH. Manufacturer: Invacare Corp., Sanford, FL. Invacare 600lb. Bariatric Bed. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 19th, 2011. Volume in Commerce: 35,747 beds. Reason: Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire. FDA recall #Z-0187-2012. FDA Enforcement Report, 12/14/11.

PELSTAR, LLC. Alsip, IL. Manufacturer: Beaverite International Limited, Kowloon, Hong Kong SAR. Health O Meter Professional Remote Display Digital Physician Scale. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 7th, 2011. Volume in Commerce: 2,498 units. Reason: There is a potential for an electric short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke, burn or burst. FDA recall #Z-0294-2012. FDA Enforcement Report, 12/14/11.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Philips Digital Diagnost Rel 3. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 25th, 2011. Volume in Commerce: 28 units. Reason: Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension, exposes printed circuit. FDA recall #Z-0313-2012. FDA Enforcement Report, 12/21/11.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands Philips Multi Diagnost Eleva with Flat Software R5.2.2. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 14th, 2011. Volume in Commerce: 27 units. Reason: Displayed Dose Area Product (DAP) is displayed by a factor 100 too low. FDA recall #Z-0371-2012. FDA Enforcement Report, 12/21/11.

PHILIPS MEDICAL SYSTEMS, San Jose, CA., Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. SKYlight Gamma Camera System. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 27th, 2011. Volume in Commerce: 658 Reason: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYlight SPECT systems may get stuck and cause unintended motion of a detector. FDA recall #Z-0247/258-2012. FDA Enforcement Report, 12/28/11.

STRYKER ENDOSCOPY, San Jose, CA. Manufacture: Stryker, Arroyo, PR. Stryker Endoscopy Energy Probe. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 25th, 2011. Volume in Commerce: 6,307 probes. Reason: An increased number of complaints for tip breaks were observed for the 3.5 mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011. FDA recall #Z-0265-2012. FDA Enforcement Report, 12/14/11.

STRYKER INSTRUMENTS DIV. OF STRYKER CORP. Portage, MI. Blades for TPS Reciprocating Saw. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 18th, 2011. Volume in Commerce: 12,631 units. Reason: There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a broken blade, infection due to an unretrieved device component, complications associated with increase time under anesthesia. FDA recall #Z-0195/0199-2012. FDA Enforcement Report. 12/14/11.