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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Beckman Coulter

Class I - Dangerous

The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

May 4, 2018 Infusion Pumps View Details →

Revolution CT 160 1.5D STD WAUK

GE Healthcare

Class I - Dangerous

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

ELITech Clinical Systems SAS

Class I - Dangerous

ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.

Apr 18, 2017 Other Medical Devices View Details →

MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

Integra LifeSciences

Class I - Dangerous

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Jun 29, 2018 Diagnostic Equipment Nationwide View Details →

VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)

bioMerieux

Class I - Dangerous

Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.

Mar 1, 2018 Diagnostic Equipment Nationwide View Details →

BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

Becton, Dickinson and Company, BD Biosciences

Class I - Dangerous

The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

May 16, 2018 Diagnostic Equipment View Details →

Zimmer Dermatone AN, Model No. 88710100

Zimmer Surgical

Class I - Dangerous

Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.

Jun 8, 2018 Other Medical Devices View Details →

Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.

Encore Medical

Class I - Dangerous

A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.

Jun 26, 2018 Surgical Instruments View Details →

CT Goldseal BrightSpeed 16 PWR TIO 2 YR

GE Healthcare

Class I - Dangerous

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

May 24, 2018 Other Medical Devices Nationwide View Details →

Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

Randox Laboratories

Class I - Dangerous

The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.

Jun 8, 2018 Diagnostic Equipment View Details →