ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
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ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Class I - Dangerous
Potential presence of particulate matter on the blood side of the dialyzer
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Class I - Dangerous
The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Class I - Dangerous
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Trumpf has identified six incidents of pinched cables.
SOMATOM Definition AS system, x-ray, tomography, computed
Siemens Medical Solutions USA
Class I - Dangerous
Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
Maquet Medical Systems USA
Class I - Dangerous
Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Abbott Laboratories
Class I - Dangerous
Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Class I - Dangerous
cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Stryker Howmedica Osteonics
Class I - Dangerous
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.