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GE Replacement Batteries (GE Healthcare) – backup power issue (2022)

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

FDAApr 18, 2022Nationwide• GE Healthcare, LLC

Medfusion Syringe Pump (Smiths Medical) – Therapy Interruption (2022)

Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001

FDAApr 18, 2022Nationwide• Smiths Medical ASD Inc.

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GE Replacement Batteries (GE Healthcare) – backup power issue (2022)

Medfusion Syringe Pump (Smiths Medical) – Therapy Interruption (2022)

HeartWare HVAD Pump (Medtronic) – Potential Weld Defect (2022)

BioPlex 2200 ToRC IgM (Bio-Rad) – Performance Concerns (2022)

Getinge CM320 Washer (Getinge) – Installation Verification (2022)

Atellica IM 1300 Analyzer (Siemens) – Erroneous T3 Results (2022)

Getinge CM320 Washer (Getinge) – Installation Verification (2022)

Sensis Diagnostic Computer (Siemens) – Software Issues (2022)

Atellica IM 1600 Analyzer (Siemens) – Erroneous T3 Results (2022)

Cobalt Cardiac Device (Medtronic) – Telemetry Error (2022)

Crome Cardiac Device (Medtronic) – Telemetry Error (2022)

Artis Icono Biplane System (Siemens) – Electrical Safety Risk (2022)

Teleflex Flex Tube (Teleflex) – Tube Damage (2022)

Gibeck Humid-Vent (Teleflex) – Tube Damage (2022)

Artis Icono Floor System (Siemens) – Electrical Safety Risk (2022)

Joysbio COVID Test (Woodside) – Unauthorized Distribution (2022)

Oral Rapid COVID Test (Woodside) – Unauthorized Distribution (2022)

Radiometer Blood Sampler (Radiometer) – Sterility Concern (2022)

HemosIL ReadiPlasTin (Instrumentation Lab) – QC Result Variability (2022)

Variant Sickle Cell CD-ROM (Bio-Rad) – Software Issue (2022)