Medical Device Oct 23, 2019
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Class II FDA: Terminated Vital Scientific N.V.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
Class II FDA: Terminated Siemens Healthcare Diagnostics, Inc.
Medical Device Oct 23, 2019
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Class II FDA: Terminated Vital Scientific N.V.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Due to low Quality Control recovery and invalid Calibration.
Class III FDA: Terminated Roche Diagnostics Operations, Inc.
Medical Device Oct 23, 2019
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Class II FDA: Terminated Vital Scientific N.V.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Class II FDA: Terminated Vital Scientific N.V.
Medical Device Oct 23, 2019
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Class II FDA: Ongoing Medtronic Vascular Galway DBA Medtronic Ireland
Medical Device Oct 23, 2019
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Class II FDA: Terminated OrthoPediatrics Corp
Medical Device Oct 23, 2019
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Class II FDA: Terminated Vital Scientific N.V.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Due to low Quality Control recovery and invalid Calibration.
Class III FDA: Terminated Roche Diagnostics Operations, Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class II FDA: Terminated ICU Medical Inc.
Medical Device Oct 23, 2019
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Class II FDA: Ongoing Integra LifeSciences Corp.