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TruScan Body (TruAbutment) – scanning accuracy problems (2023)

Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately

FDADec 27, 2023CA, CO, FL +13 more• TruAbutment Inc.

Impella Catheters (Abiomed) – myocardial wall risk (2023)

IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

High

FDADec 27, 2023Nationwide• Abiomed, Inc.

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TruScan Body (TruAbutment) – scanning accuracy problems (2023)

Impella Catheters (Abiomed) – myocardial wall risk (2023)

Impella Catheters (Abiomed) – fiber contamination risk (2023)

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)

GE Lullaby Incubator (GE Healthcare) – bedside panel issue (2023)

GE Neonatal Incubator (GE Healthcare) – bedside panel problem (2023)

GE Care Plus Hood (GE Healthcare) – bedside panel issue (2023)

Power Knee (Ossur) – battery failure risk (2023)

GE Voluson Probe (GE Healthcare) – image artifact risk (2023)

Aligned Lower Extremity Pack (Windstone) – saline sterility issue (2023)

Allograft Filler Tube (Musculoskeletal) – filling process risk (2023)

Allograft Filler Tube (Musculoskeletal) – filling process risk (2023)

Baxter Exactamix Pro (Baxter) – overfill software error (2023)

Aligned Ocular Pack (Windstone) – saline sterility concern (2023)

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Eleos Collar Stem (Onkos) – mislabeling problem (2023)

Aligned Closure Kit (Windstone) – saline sterility concern (2023)

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Baxter Exactamix Pro (Baxter) – overfill software error (2023)

FLEXSelect Latex Elastics (G & H Wire) – mislabeling risk (2023)