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QUARTERLY SUMMARY: April - June 2012

A summary of FDA recalls, safety alerts, and manufacturer field corrective actions as reported for the first quarter of the year. This information is a snapshot and chronology of the reported events. For additional details refer to the cited volume of original publication or contact the Home Office.

CINCINNATI SUB-ZERO PRODUCTS, INC. Cincinnati, OH. ECMO Heaters. Class II. Reason: Design error. The probe jack contacts (terminals) on certain of the firm’s ECMO Heater devices are located to close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a service tech, operator / user, and / or patient could be exposed to electric shock during device servicing or use. Vol. 21:06.

COVIDIEN LP, North Haven, CT. Roticulator Single Use Stapler. Class II. Reason: Potential for the sterility barrier to be comprised. Vol. 21:06.

ETHICON ENDO-SURGERY INC., Cincinnati, OH. HPBLUE HARMONIC Blue Hand Piece. Class II. Reason: The problem occurs after successful set-up and initial use of HARMONIC Hand Pieces with the Generator 300. The procedure is interrupted when the Generator 300 goes into stand-by mode after one minute of cumulative activation time. Once the generator is in stand-by mode, the device cannot be activated to complete the procedure without fully re-setting the system. Vol. 21:06.

GE HEALTHCARE, LLC, Waukesha, WI. Innova X Ray Imaging Systems. Class II. Reason: When the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation. Vol 21:04.

GE HEALTHCARE, LLC, Waukesha, WI. GE Healthcare Automatic Mobile X-Ray (AMX) series. Class II. Reason: GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product related to the light field to x-ray field edge alignment. Vol. 21:05.

GENERAL ELECTRIC MED SYSTEMS, Waukesha, WI. GE Healthcare Radiographic Systems. Class II. Reason: An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath. Vol. 21:06.

HOSPIRA INC., Lake Forest, IL. Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. LifeShield Primary Plumset. Class II. Reason: The LifeShield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention. Vol. 21:05.

LEICA MICROSYSTEMS INC., Buffalo Grove, IL. Manufacturer: Leica Microsystems (Schweiz) Ag. Heerbrugg, Switzerland. Touch Panel / Control Unit Carrier of the Swingarm, component of Surgical Microscope. Reason: The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel / control unit of the surgical microscope to disconnect, which potentially could result in them falling. Vol 21:04.

MAQUET INC., Wayne, NJ. Manufacturer: Maquet Critical Care AB, Solna Sweden. Servo-i and Servo-s ventilator system. Class II. Reason: The Servo-i and Servo-s ventilator systems equipped with specific revision of the AC / DC convertor can result in electric shock during servicing. Vol 21:04.

MOOG MEDICAL DEVICES GROUP, Salt Lake City, UT. Curlin Ambulatory Infusion Pump System. Class II. Firm Reason: Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. Vol 21:04.

NELLCOR PURITAN BENNETT INC., (dba Covidien LP), Boulder, CO. Manufacturer: Covidien LLC, Norwood, MA. BIS Bilateral Sensors. Class I. Reason: During manufacture, circuit traces were reversed which causes inaccurate display of information.Vol. 21:04.

ORTHO-CLINICAL DIAGNOSTICS, Rochester, N.Y. VITROS Immunodiagnostic System. Class II. Reason: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. Vol. 21:05.

ORTHO CLINICAL DIAGNOSTICS, Rochester, NY. VITROS 5600 Integrated System Software. Class II. Reason: Recall because of an anomaly that may inadvertently add a surfactant to a CurveTip position. Vol. 21:06.

PHILIPS HEALTHCARE INC., Andover, MA. MD Eleva System. Class II. Reason: The air karma rate is not displayed correctly on the user interface. Vol 21:04.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. MultiDiagnost Eleva IITV. Class II. Reason: Incorrect Skin Dose Calculation. AKR (Air Karma Rate) displayed and stored in patient records is too low. Vol 21:04.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Allura X-ray System. Class II. Reason: The monitor Ceiling suspension may fail, which may cause the monitor to drop. Vol. 21:05.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Philips Digital Diagnost Systems. Class II. Reason: Potential misdiagnosis due to improper automatically stitched images and improper image ruler handling. Vol. 21:05.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance Workspace Portal. Class II. Reason: Incorrect Standardized Uptake Value (“SUV”) values are displayed in two instances: 1. After loading PET data (with Slope value different from 1) into the Quick Review application from a remote device and 2. During the loading the above mentioned type of PET data in to the CT viewer application from a remote device. Vol 21:04.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance 64 and Ingenuity CT X Ray Systems. Class II. Reason: Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan. Vol 21:04.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance & GEMINI X Ray Systems. Class II. Reason: TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list. Vol. 21:05.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance iCT. Class II. Reason: Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds. Vol. 21:06.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance 16, 40, Big Bore, iCT CT Scanning Systems. Class II. Reason: Component defect. The metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm’s CT scanning systems were not manufactured to specification and may crack. Vol. 21:06.

PHILIPS MEDICAL SYSTEMS (Cleveland) Inc., Cleveland, OH. Brilliance iCT and iCT SP X Ray Systems. Class II. Reason: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances, including calibration ring artifacts that may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds. Vol. 21:06.

PLASMA SURGICAL INC., Roswell, GA. PlasmaJet Open Surgery Handpiece. Class II. Reason: Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water coolant from the handpiece in use. Vol. 21:06.

QRS DIAGNOSTIC, Maple Grove, MN. Universal ECG 12 Channel ECG (IEC). Class II. Reason: The chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretation by the Office Medic Software. Vol 21:04.

SALTER LABS, Arvin, CtelephoneA, Salter Labs Bubble Humidifier. Class I. Reason: A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak. Vol. 21:04.

SCOTTCARE CORP., Cleveland, OH. TeleSentry Multi-parameter Ambulatory Telemetry. Class II. Reason: Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card and the device stops working. Vol. 21:05

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. MOSAIQ System. Class II. Reason: Images used in treatment planning may belong to another patient causing a risk of treatment to wrong area. Software update is needed to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A. Vol 21:04.

SIEMENS MEDICAL SOLUTIONS USA, INC., Malvern, PA. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. AXIOM Artis and AXIOM Artis zee modular systems. Class II. Reason: There is a potential misalignment in the connection of the remote foot switch and the stationary unit. Vol. 21:05.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Siemens AG, Medical Solutions, Kemnath, Germany. Linear accelerator with a 550 TxT Treatment Table. Class II. Reason: Siemens has received reports where a dropping down of the 550 TxT Treatment Table was observed while the table was being moved downwards during operation by means of the hand control. Vol. 21:05.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Siemens AG, Medical Solutions, Kemnath, Germany. ARTISTE or ONCOR Linear Accelerators with Multi Leaf Collimator. Class II. Reason: Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the “Motion Stop” button followed by “Reset” several times during the treatment of one beam or one segment (issue 1). Additionally, there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2). Vol. 21:05.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Siemens AG, Medical Solutions, Kemnath, Germany. Siemens branded ONCOR or PRIMUS linear accelerator. Class II. Reason: The firm became aware of a potential issue with Siemens branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury. Vol. 21:05.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, CA. ACUSON S2000 Ultrasound Systems. Class II. Reason: When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. Vol. 21:06.

SMITH & NEPHEW, INC. Endoscopy Division, Andover, MA. Manufacturer: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK. Smith & Nephew 560P High Definition Camera Control Unit. Class II. Reason: May experience intermittent loss of video due to a defective board component. Vol. 21:05.

SMITHS MEDICAL ASD, INC. Gary, IN. Bivona Tracheostomy Tubes. Class I. Reason: Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed, Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is immediately available. Vol. 21:04.

SPACELABS HEALTHCARE, LLC. Issaquah, WA. Pathfinder SL Holter Analyzer. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 11th, 2012. Volume in Commerce: 114 units. Reason: The firm received reports of the pathfinder SL software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart. In addition, QTc values will not update after moving the marker. FDA recall #Z-1831-2012. FDA Enforcement Report, 6/27/12.

STRYKER MEDICAL DIVISION OF STRYKER CORP., Portage, MI. Stryker Beds (Epic Critical, Epic Zoom, Secure & Critical). Class II. Reason: Plate Body Installed on Secure II and EPIC units since November 21st, 2007 and installed on units upgraded between 9/1/2004 through 11/20/2007, demonstrated a component life of approx. 2 years of simulated use. While the correct brake plates were installed on these beds, updated maintenance information was not included. Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Vol. 21:05.

VARIAN MEDICAL SYSTEMS, INC. ONCOLOGY SYSTEMS, Palo Alto, CA. FastPlan Treatment Planning System. Class II. Reason: An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the user elects to “Discard” that slice, an incorrect calculation of the isocenter location may result. Vol. 21:05.