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February 2011 - vol. 20:03

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 NEWS /MEDWATCH

1) FDA clears first diagnostic radiology application for mobile devices: Provides wireless access to medical images for iPhone, iPad users.

A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.

The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.

“This important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.

Radiology images taken in the hospital or physician’s office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.

In its evaluation, the FDA reviewed performance test results on various portable devices. These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions.

The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model. The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician’s ability to discern subtle differences in contrast. In addition, a safety guide is included within the application. Feb. 4, 2011

2) B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES

Class I Recall - Hardware May Become Unresponsive

ISSUE: Infusion systems upgraded with the Motorola compact flash hardware and supporting software, when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication, can potentially induce a memory leak that can cause the Management Processor to become non-responsive. This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. There is no visual error warning to alert the user that the pump is not working.

BACKGROUND: The B. Braun Outlook 400ES Safety Infusion System is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid when the IV fluid container is lower than the pump and provides the accurate volume of all standard IV fluid, including blood, lipids, and Total Parenteral Nutrition (TPN).

RECOMMENDATION: Customers should deactivate the wireless communication on their pumps and return them to the manufacturer. Feb. 1, 2011

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ELEKTA, INC., Norcross, Georgia: Manufacturer: Elekta Oncology Systems (FMRL Philipps) Crawley, West Sussex, UK. Precise Treatment Table. Class II. Firm initiated recall ongoing. Firm notified users by letter dated December 24, 2008. Volume in Commerce: 597 units. Reason: Possible error in the table longitudinal position. FDA recall #Z-1030-2011. FDA Enforcement Report, 02/09/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, Wisconsin. Monitors: power supply boards on Dash 3000, 4000, and 5000 monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter dated October 8, 2010. Volume in Commerce: 137 units. Reason: The power supply board may fail due to insufficient solder of a component. Insufficient solder could result in excess EMC emissions, smoking of components and eventual failure of the power supply, tripping of the fuse and immediate shutdown resulting in as loss of monitoring that could delay recognition of a clinical event. FDA recall #Z-0359-2011. FDA Enforcement Report, 02/02/11.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, Wisconsin. Transport Pro Monitors: with the CARESCAPE Patient Data Module. Class II. Firm initiated recall ongoing. Firm notified users by letter dated September 17, 2010. Volume in Commerce: 3,256 units. Reason: Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time depending on how much the units is actually in service per day. Transport Pro contains an internal timer that is used to control the software and remind users to perform preventive maintenance. When this internal timer rolls-over, the Transport Pro will display an EC1 message. If the Transport Pro is continued to be used without clearing the EC1 message, after additional 19 days of service time, loss of communication between the Transport Pro and a connected CARESCAPE Patient Data Module (PDM) will occur. This results in the loss of the displayed parameter information (e.g. waveforms, numerical data, and alarms). This condition affects all released versions of software. FDA recall #Z-0363-2011. FDA Enforcement Report, 02/02/11.

MIZUHO ORTHOPEDIC SYSTEMS INC., Union City, California. Operating Table: Mizuho Profx 6850 with orthopedics accessories. Class II. Firm initiated recall ongoing. Firm notified users by letters April 1, 2010. Volume in Commerce: 17 units. Reason: Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact. FDA recall #Z-0924-2011. FDA Enforcement Report, 02/02/11.

RADIOMETER AMERICA INC., Westlake, Ohio: Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Blood Analyzer: ABL 90 FLEX. Class II. Firm initiated recall ongoing. Firm notified users by letters November 16, 2010. Volume in Commerce: 432 units. Reason: A software error may result in a patient mix up. FDA recall #Z-1011-2011. FDA Enforcement Report, 02/09/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound: 1) Acuson Antares PE Product 5.0; 2) Acuson S2000; 3) Acuson with Physio Module. Class II. Firm initiated recall ongoing. Firm notified users by letter beginning October 2, 2009. Volume in Commerce: 67 units. Reason: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images. FDA recalls #Z-1005/1007-2011. FDA Enforcement Report, 02/09/11.

SMITHS MEDICAL ASD, INC., Saint Paul, Minnesota. Infusion Pump: Smiths Medical CADD Solis Ambulatory Infusion Pump. Class II. Firm initiated recall ongoing. Firm notified users by letters dated January 13, 2011. Volume in Commerce: 2,903 (2539 nationwide) units. Reason: Increasing trend of the cassette lock mechanism becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs or administration set. FDA recall #Z-1033-2011. FDA Enforcement Report, 02/09/11.

VITAL SIGNS COLORADO, Englewood, Colorado. Laryngoscope Handle. Class II. Firm initiated recall ongoing. Firm notified users by letter dated December 20, 2010. Volume in Commerce: 2,202 units. Reason: Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination. FDA recall #Z-1024-2011. FDA Enforcement Report, 02/09/11.