An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior…
The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could…
Class IIFDA: TerminatedPhilips Electronics North America Corporation
Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that…
Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Product sterility may be compromised due to unsealed packaging.
Class IIFDA: TerminatedArrow International Inc.
About the 2018 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.