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October 2012 - vol. 21:10

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: ACCUTRON INC., Phoenix, AZ. Flow Meter, CM Assembly. Class I. Firm initiated recall ongoing. Firm notified users by letter on April 29th, 2012. Volume in Commerce: 220 units. Reason: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrectmanner. FDA recall #Z-0017/0020-2013. FDA Enforcement Report, 10/17/12.

CLASS I RECALL: BAXTER HEALTHCARE INC., Round Lake, IL. Baxter Interlink System Buretol Solution Set. Class I. Firm initiated recall ongoing. Firm notified users by letter on September 7th, 2012. Volume in Commerce: 5,027,417 units. Reason: Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette. FDA recall #Z-0012/0015-2013. FDA Enforcement Report, 10/17/12.

3M COMPANY – HEALTHCARE. St. Paul, MN. 3M Steri-Vac Gas Sterilizer / Aerator. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 13th, 2012. Volume in Commerce: 61units in US. Reason: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechanism. FDA recall #Z-0022-2013. FDA Enforcement Report, 10/17/12.

HOLOGIC, INC., Bedford, MA. Hologic Fluoroscan Mini C-Arm. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 14th, 2012. Volume in Commerce: 460 units. Reason: InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180°around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be flipped 180° around vertical axis as well as 180° around a horizontal axis. FDA recall #Z-2452-2012. FDA Enforcement Report, 10/3/12.

INVACARE CORPORATION, Elyria, OH. Invacare I-Fit Shower Chair. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 6th, 2012. Volume in Commerce: 21,168 chairs. Reason: On August 6, 2012, Invacare voluntarily recalled the Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received. FDA recall #Z-2461-2012. FDA Enforcement Report, 10/3/12.

MOOG MEDICAL DEVICES GROUP, Salt Lake City, UT. Curlin Infusion Administration Set. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 26th, 2012. Volume in Commerce: 12,000 sets. Reason: This recall is the same issue for the FDA processed recall initiated by MOOG Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots (340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905) associated with this recall were inadvertently omitted from the original recall which has been terminated by the FDA. FDA recall #Z-0072-013. FDA Enforcement Report, 10/24/12.

PHILIPS HEALTHCARE INC., Andover, MA. Philips HeartStart XL Defibrillators / Monitors. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 11th, 2012. Volume in Commerce: 2,500 units. Reason: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. FDA recall #Z-0011-2013. FDA Enforcement Report, 10/10/12.

PHILIPS HEALTHCARE INC., Andover, MA. Philips Digital Diagnost with patient carriage. Class II. Firm initiated recall ongoing. Firm notified users by letter on Sept. 12th, 2012. Volume in Commerce: 536 units. Reason: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator. FDA recall #Z-2494-2012. FDA Enforcement Report, 10/10/12.

PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC., Cleveland, OH. Computed Tomography X Ray Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 21st, 2012. Volume in Commerce: 112 units. Reason: A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. FDA recall #Z-2451-2012. FDA Enforcement Report, 10/3/12.

REMINGTON MEDICAL INC., Alpharetta, GA. Automatic Cutting Needles. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 29th, 2012. Volume in Commerce: 800 needles. Reason: Sterility of the product may be compromised. FDA recall #Z-0028-2013. FDA Enforcement Report,10/17/12.

SIEMENS MEDICAL SOLUTIONS USA INC., Malvern, PA. Siemens Magnetom Skyra, Verio, Spectra and Biograph MRI. Class II. Firm nitiated recall ongoing. Firm notified users by letter on Sept. 12th, 2012. Volume in Commerce: 370 units. Reason: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the coil can heat up in the area of the electronic housing (white plastic lids). FDA recall #Z-2464-2012. FDA Enforcement Report, 10/3/12.

STANLEY SECURITY SYSTEMS, Lincoln, NE. Tabs Professional Monitor Model 25022. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 4th, 2012. Volume in Commerce: 23,938 units. Reason: The monitor may fail to sound an alarm. FDA recall #Z-2488/2492-2012. FDA Enforcement Report, 10/10/12.

TRUMPF MEDICAL SYSTEMS INC., Charleston, SC. Helion and Xenion surgical lights. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 19th, 2012. Volume in Commerce: 275 units. Reason: Incidents regarding fractures of the front joint of the spring arm have been reported. FDA recall #Z-0077-2013. FDA Enforcement Report, 10/24/12.