The Commitment Makes The Difference

“Providing quality and cost-effective biomedical equipment services since 1978.”

Around the MBI Circuit

Our focus is on you

Through constant communication and the ability to adjust to a changing set of needs, Modern and our clients are able to build a successful partnership. Whatever they are, Modern’s clients know we offer the flexibility to deliver a service program to best suit their operational and financial needs.

December 2012 - vol. 21:12

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.

CLASS I RECALL: BUNNELL, INC., Salt Lake City, UT. Patient Circuit used with the Life Pulse High Frequency Ventilator. Firm initiated recall ongoing. Firm notified users by press release on November 19th, 2012. Volume in Commerce: 5,743 units. Reason: Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012. FDA recall #Z-0514-2013. FDA Enforcement Report, 12/26/12.

CLASS I RECALL: NATUS MEDICAL INCORPORATED, Seattle, WA. Olympic Cool-Cap System. Firm initiated recall ongoing. Firm notified users by phone on May 9th, 2012. Volume in Commerce: 324 units. Reason: The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing. FDA recall #Z-0447-2013. FDA Enforcement Report, 12/12/12.

CLASS I RECALL: VERATHON INC., Bothell, WA. Glidescope Video Laryngoscope. Firm initiated recall ongoing. Firm notified users by letter on October 25th, 2012. Volume in Commerce: 2,710 units. Reason: Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking. FDA recall #Z-0478-2013. FDA Enforcement Report, 12/19/12.

ADVANCED STERILIZATION PRODUCTS, Irvine, CA. STERRAD CYCLESURE 24 Biological Indicator. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 3rd, 2012. Volume in Commerce: 38,532 units. Reason: Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life. FDA recall #Z-0520-2013. FDA Enforcement Report, 12/19/12.

COVIDIEN LLC DBA UNI-PATCH, Wabasha, MN. Self Adhering Electrodes for use with TENS / NMES. Class II. Firm initiated recall ongoing. Firm notified users by e-mail on February 9th, 2012. Volume in Commerce: 37,036 pouches. Reason: Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut. FDA recall #Z-0498/0501-2013. FDA Enforcement Report, 12/19/12.

GE HEALTHCARE, LLC., Waukesha, WI. GE Healthcare Optima XR 220amx. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 1st, 2012. Volume in Commerce: 217 units. Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade. FDA recall #Z-0448/0450-2013. FDA Enforcement Report, 12/5/12.

GE HEALTHCARE, LLC., Waukesha, WI. GE Healthcare Dash 3000/4000/5000 Patient Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 26th, 2012. Volume in Commerce: 119,260 devices. Reason: GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors. FDA recall #Z-0494-2013. FDA Enforcement Report, 12/26/12.

HOSPIRA INC., Lake Forest, IL. Plum A+ Single Channel Infusion Pumps. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 26th, 2012. Volume in Commerce: N/A. Reason: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise. FDA recall #Z-0481/0483-2013. FDA Enforcement Report, 12/19/12.

INVIVO CORPORATION, Orlando, FL. Expression MRI Patient Monitoring System. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 15th, 2012. Volume in Commerce: 543 units. Reason: The Expression MRI Patient Monitoring System is being recalled because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall. FDA recall #Z-0468-2013. FDA Enforcement Report, 12/12/12.

KIMBERLY CLARK CORPORATION, Roswell, GA. Patient Warming System-Model 1000. Class II. Firm initiated recall ongoing. Firm notified users by two or more of the following: email, letter, fax, press release, telephone, or visit on September 16th, 2012. Volume in Commerce: 400 units. Reason: Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. FDA recall #Z-0451-2013. FDA Enforcement Report, 12/5/12.

MEDRAD, INC., Indianola, PA. Medrad ® Continuum MR Infusion Pump. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 18th, 2012. Volume in Commerce: 1,229 pumps. Reason: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. In addition, they are recalling select Continuum pumps, calibrated using the tubing associated with this recall. FDA recall #Z-0595/0605-2013. FDA Enforcement Report, 12/26/12.

MINDRAY DS USA INC., DBA MINDRAY NORTH AMERICA, Mahwah, NJ. DPM 6/7 Patient Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 11th, 2010. Volume in Commerce: 124 units. Reason: There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable: Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations. FDA recall #Z-0513-2013. FDA Enforcement Report, 12/19/12.

MINDRAY DS USA INC., DBA MINDRAY NORTH AMERICA, Mahwah, NJ. Mindray V12 Size V Series Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 24th, 2012. Volume in Commerce: 180 units. Reason: Mindray has identified an issue with the V series Monitor where the monitors touch screen may stop responding to touch. FDA recall #Z-0528-2013. FDA Enforcement Report, 12/26/12.

ROCHE DIAGNOSTICS OPERATIONS, INC., Indianapolis, IN. Cobas 8000 Modular Analyzer Series. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 1st, 2012. Volume in Commerce: 78 analyzers. Reason: On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (CREJ2), Urea (UREAL), C Reactive Protein (CRPL3). FDA recall #Z-0473-2013. FDA Enforcement Report, 12/12/12.

ROCHE MOLECULAR SYSTEMS, INC., Branchburg, NJ. AMPLILINK software used with various COBAS Analyzers. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 25th, 2012. Volume in Commerce: 9,250 units. Reason: Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+. FDA recall #Z-0484/0493-2013. FDA Enforcement Report, 12/19/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Malvern, PA. MAVIG PORTEGRA 2 System in conjunction with Siemens AX system ceiling mounted surgical light. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 10th, 2012. Volume in Commerce: 1,315 units. Reason: A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. FDA recall #Z-0515-2013. FDA Enforcement Report, 12/19/12.

STRYKER INSTRUMENTS DIV. OF STRYKER CORPORATION, Portage, MI. Neptune 2 Rover Ultra. Class II. Firm initiated recall ongoing. Firm notified users by two or more of the following: email, letter, fax, press release, telephone, or visit on May 24th, 2011. Volume in Commerce: 6,019 units. Reason: Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, back pain could result due to multiple exposures. FDA recall #Z-0454/0455-2013. FDA Enforcement Report, 12/12/12.