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BD Pyxis MedStation Auxiliary Tower (CareFusion) – fluid ingress risk (2024)

Fire/Burn Risk

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

High

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

Total Knee Arthroplasty System (Stryker) – software error (2024)

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Moderate

FDAApr 15, 2024Nationwide• Stryker Orthopaedics

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BD Pyxis MedStation Auxiliary Tower (CareFusion) – fluid ingress risk (2024)

Total Knee Arthroplasty System (Stryker) – software error (2024)

MyoSPECT System (GE Medical) – lead cover handle risk (2024)

BD Pyxis Anesthesia Station 4000 (CareFusion) – fluid ingress risk (2024)

Tri-Staple 2.0 Reload (Unknown) – cartridge damage risk (2024)

BD Pyxis Anesthesia Station (CareFusion) – fluid ingress risk (2024)

BD Pyxis MedStation 4000 System (CareFusion) – fluid ingress risk (2024)

APTUS TriLock Screw (Medartis) – incorrect length (2024)

Arial Mobile Application (Securitas) – alert restart issue (2024)

FDR Visionary Suite (Fujifilm) – tube support risk (2024)

Noblus AC Adapter (Fujifilm) – power socket overheat (2024)

Leica HistoCore PEGASUS Processor (Leica) – reagent level issue (2024)

Astra EV Titanium Abutment (Preat) – incorrect packaging (2024)

VITROS Free T3 Reagent Pack (QuidelOrtho) – Biased Results (2024)

Pressio Intracranial Pressure Kit (Sophysa) – CSF Leakage Risk (2024)

Spectrum IQ Infusion Pump (Baxter) – front panel crack (2024)

VITROS Free T3 Calibrators (QuidelOrtho) – result bias (2024)

CRITIKON ONE-CUF Blood Pressure Cuffs (GE Healthcare) – Inaccurate Measurements (2024)

Pain Services CDS Kit (Medline) – Syringe Quality Issues (2024)

Permanent Pacing Kit (Medline) – Unspecified Issue (2024)