Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for…
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for…
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time…
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In…
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.