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November 2010 vol. 19:15

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 MEDWATCH Posting: November 4, 2010

Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall –

Motor Encoder Failures

ISSUE: FDA and Hospira notified healthcare professionals of a Class 1 recall of these infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates.

BACKGROUND: Symbiq Infusers are infusion pumps intended for the delivery of fluids by parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Hospira mailed an Urgent Device Field Correction to affected customers on February 22, 2010, and a Recall Notification on February 22, 2010. Information regarding additional recall actions was also provided in an update Recall Notification letter on October 4, 2010. The affected units were distributed from December 23, 2006 to January 22, 2010.

RECOMMENDATION: Until Hospira can upgrade all Symbiq pumping mechanisms, corrected loaner pumps will be provided at no cost to customers for critical care areas. Until loaner or corrected pumps are in place in critical care areas, Hospira urges customers to consider an alternate method to administer therapy. All lots affected can be found in the List Number Configurations in the FDA Recall Notice.

FDA NEWS RELEASE: November 4, 2010:

FDA reclassifies certain digital mammography devices

Devices capturing digital image of breasts to be Class II

The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.

These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film. When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.

Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices.

“Our decision to reclassify these devices is consistent with feedback we’ve received from public discussions with appropriate medical and scientific experts as well as our stronger understanding of how these systems work,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk among devices and include such products as heart valves and orthopedic implants. Companies must typically submit a premarket approval application for a Class III device, which requires proof of safety and effectiveness before the product can be approved for marketing. Many Class III devices involve new technology that has not been widely used.

Class I and Class II devices pose lower risk and include adhesive bandages, wheelchairs, and many medical imaging technologies, such as MRI scanners and screen-film X-ray mammography. Class III devices require submission of a premarket notification, also known as a 510(k), to establish that the product is substantially equivalent to a device already on the market.

Along with the digital mammography reclassification, the FDA is releasing a “special controls” guidance for industry that describes what evidence will be needed to show substantial equivalence for these systems, including technical device specifications, images of standard test objects, and a sample set of patient images.

The FDA has approved five full field digital mammography systems since 2000, all were approved as Class III devices. About 70 percent of the mammography units in use are digital and 70 percent of certified U.S. mammography facilities have at least one digital unit, according to FDA reports from certified mammography facilities.

Other than skin cancer, breast cancer is the most common type of cancer among women in the United States. An estimated 207,100 new cases of breast cancer in women will be diagnosed in 2010, according to the National Cancer Institute.

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HILL-ROM, INC., Batesville, Indiana: Manufacturer: Optima Healthcare, Inc., Tao-Yuan, Taiwan. Patient Beds: 1) 305 Bed, P1441B Non-electric; 2) 405 Bed, P1440B, electric; 3) Basic Care Bed, P1440A, electric; 4) Basic Care Bed, P1441A, non-electric. Class II. Firm initiated recall ongoing. Firm notified users by letter dated September 16, 2009. Volume in Commerce: 11,056 units. Reason: The flexing of the junction of the sleep deck’s head and mid sections can create excessive pressure on the pivot pin E ring, which could cause the E-ring to come off. FDA recalls #Z-2167/2170-2010. FDA Enforcement Report, 11/03/10.

NATUS MEDICAL, INC., Mundelein, Illinois: Manufacturer: Sonamed Corp., Waltham, Massachusetts. Auditory Stimulator: SonaMed Clarity System II. Firm initiated recall ongoing. Firm notified users by letters dated June 4, 2010. Volume in Commerce: 284 units. Reason: There is insufficient evidence to support any claims for safety and efficacy on the SonMed Clarity devices. FDA recall #Z-2165-2010. FDA Enforcement Report, 11/03/10.

PHILIPS MEDICAL SYSTEMS (Cleveland), INC., Cleveland, Ohio. CT: Brilliance iCT Heavyweight Gantry Scanner. Firm initiated recall ongoing. Firm notified users by letters dated April 14, 2010. Volume in Commerce: 9 units: DC, Georgia, Illinois, Indiana, NY, Ohio, and international. Reason: The gentry covers of the iCT have a latch at the base of the system which holds the cover in the closed position. During the course of maintenance the CT Field Service Engineer, (FSE), will activate this latching mechanism which in turn has a potential to penetrate the insulation on cabling which carries 277 VAC. If the latch does come in contact with the cabling there is a potential that the FSE could receive an electrical shock. FDA recall #Z-2460-2010. FDA Enforcement Report, 11/03/10.

SONOSITE, INC., Bothell, Washington. V or H Universal Stand: PowerPark accessory comprised of two parts: a) the stand mounted assembly and a docking assembly. Provides a docking and charging station for the V and H Universal Stands. Class II. Firm initiated recall ongoing. Firm first notified users by telephone on May 27, 2010 and letter on June 1, 2010. Volume in Commerce: 26 units. Reason: PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment. FDA recall #Z-2116-2010. FDA Enforcement Report, 11/03/10.

STRYKER MEDICAL DIVISION of STRYKER CORP., Portage, Michigan. Patient Beds: 1) Epic II Critical Care Bed, Model 2030/2031; 2) Zoom Critical Care Bed, Model 2040. Class II. Firm initiated recall ongoing. Firm notified users by letters dated May 14, 2010. Volume in Commerce: 14,060 units. Reason: The Fowler mechanism may malfunction, preventing it from being lowered into a flat position. FDA recalls #Z-2586/2587-2010. FDA Enforcement Report, 11/03/10.

STRYKER MEDICAL DIVISION of STRYKER CORP., Portage, Michigan. Stretchers: 1) Atlas Transport Stretcher with Zoom, Model 660Z; 2) M-Series Stretchers, Model 1025; 3) Renaissance Series Stretchers Model 1231Z Emergency Care with Zoom; 4) Renaissance Series Stretchers, Model 1731Z PACU with Zoom; 5) Stryker power cord kits. Class II. Firm initiated recall ongoing. Firm notified users by letters dated March 19, 2010. Volume in Commerce: 4,677 stretchers; 238 power cord kits. Reason: The retractable cord stretchers were fitted with power cords manufactured, by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. FDA recalls #Z-2183/2187-2010. FDA Enforcement Report, 11/03/10.