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March 2012 - vol. 21:03

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.

CLASS I RECALL: B. Braun Medical, Inc. Allentown, PA. Infusomat Space Pump.Firm initiated recall ongoing. Firm notified users by letter on August 16th, 2011. Volume in Commerce: 5,769 in CA and MO. Reason: Potential for breakage of anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of the IV set roller clamp, the anti-free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. FDA recall #Z-1015-2012. FDA Enforcement Report, 3/7/12.

ADVANCED STERILIZATION PRODUCTS, Irvine, CA. STERRARD 200 Sterilizer. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 27th, 2011. Volume in Commerce: 395 units. Reason: ASP determined that an internal filter in the vacuum pump on the STERRARD 200 System is subject to wear over time. FDA recall #Z-0741-2012. FDA Enforcement Report, 3/14/12.

CARL ZEISS INC., Thornwood, NY. Manufacturer: Carl Zeiss MicroImaging GmbH, Goettingen, Germany. Microimaging Laser – TIRF and DirectFRAP Imaging System. Class II. Firm initiated recall ongoing. Firm notified users by letter in April 2011. Volume in Commerce: 111 units. Reason: The manufacturer confirmed that the opto-semiconductor sensors can be triggered by exposure to incandescent lighting. The safety interlock is in place to prevent unintended exposure to Class 3B laser radiation. FDA recall #Z-1128/1129-2012. FDA Enforcement Report, 3/7/12.

FLIGHT MEDICAL LTD., Lod, Israel. V24-00400-29 Cable to the Newport HT50 Ventilator. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 23rd, 2011. Volume in Commerce: 363 units. Reason: A problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off. FDA recall #Z-1041-2012. FDA Enforcement Report, 3/14/12.

GE HEALTHCARE, LLC, Waukesha, WI. Manufacturer: GE Medical System Israel Ltd, Tirat Hacarmel, Israel. GE Discovery NM/CT 670 and NM 630. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 13th, 2012. Volume in Commerce: 89 units. Reason: GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of the Discovery NM/CT 670 and NM 630 system that may impact operator safety. The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. Another issue is that the lead cover handle separation could result in plate swing resulting in potential injury to service personnel. FDA recall #Z-1110/1111-2012. FDA Enforcement Report. 3/14/12.

LINET AMERICAS, INC. Charlotte, NC. Manufacturer: Linet Spol Sr.O, SLany, Czech Republic. Linet Remote Handset for Multicare Eleganza 3 and Eleganza Smart hospital beds. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 9th, 2011. Volume in Commerce: 29,252 units. Reason: The premature failure of the Remote Handset buttons may result in unintended movement of the bed. FDA recall #Z-0738-2012. FDA Enforcement Report, 3/7/12.

MINDRAY DS USA, INC., D.B.A. MINDRAY NORTH AMERICA, Mahwah, NJ. V Series Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 14th and 17th, 2011. Volume in Commerce: 542 units. Reason: A system database corruption may occur that causes the V Series Monitor to reset. FDA recall #Z-1102-2012. FDA Enforcement Report, 3/7/12.

OLYMPUS AMERICA INC. Center Valley, PA. Manufacturer: Olympus Winter & Ibe Gmbh & Co., Hamburg, Germany. Olympus Endoscopic Electrosurgical Unit. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 27th, 2011. Volume in Commerce: 591 units. Reason: Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements. FDA recall #Z-0828/0829-2012. FDA Enforcement Report. 3/14/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance CT System (Big Bore, 64 CT, and Ingenuity). Class II. Firm initiated recall ongoing. Firm notified users by letter on October 19th, 2011. Volume in Commerce: 9 units. Reason: Software errors. A number of non-conformances were logged during in house testing and external validation testing equipped with software version 3.5 Beta 2. FDA recall #Z-0777/0779-2012. FDA Enforcement Report, 3/14/12.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medizin System Boblingen, Germany. Philips IntelliVue Patient Monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 7th, 2012. Volume in Commerce: 85,534 units. Reason: Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor. FDA recall #Z-1134-2012. FDA Enforcement Report, 3/14/12.

SIEMENS MEDICAL SOLUTIONS USA INC., Malvern, PA. Manufacturer: Siemens AG, Medical Solutions, Business Unit XP. Erlangen, Germany. Siemens syngo Imaging XS. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 26th, 2011. Volume in Commerce: 128 units. Reason: Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images / series from the Patient Browser using the thumbnails may cause unintended deletion of images / series. FDA recall #Z-1064-2012. FDA Enforcement Report, 3/14/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Linear Accelerators with RT Therpaist Workspace, version 4.1 Class II. Firm initiated recall ongoing. Firm notified users by letter on January 22nd, 2012. Volume in Commerce: 182 units. Reason: Software upgrade to installed base to the lateset release of the RT Therpaist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment. FDA recall #Z-1092-2012. FDA Enforcement Report, 3/14/12.

TOSHIBA AMERICAN MEDICAL SYSTEMS INC., Tustin, CA. Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. TSX-301A and 301B AQUILION ONE System. Class II. Firm initiated recall ongoing. Firm notified users by letter on January 3rd, 2012. Volume in Commerce: 82 units Reason: The recall was initiated because Toshiba has confirmed that there is a potential software issue for the TSX-301A and 301B. FDA recall #Z-1034/1035-2012. FDA Enforcement Report. 3/21/12.

VARIAN MEDICAL SYSTEMS, INC. Palo Alto, CA. Varian brand ARIA Radiation Oncology. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 16th, 2011. Volume in Commerce: 2,235 units. Reason: The Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation. FDA recall #Z-0713-2012. FDA Enforcement Report. 3/7/2012.