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Power Cords (Baxter) – Insulation Rating Problem (2024)

Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.

Moderate

FDAMar 26, 2024IL, NY• Baxter Healthcare Corporation

Spot Vision Screener (Baxter) – Power Cord Insulation Issue (2024)

Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.

Moderate

FDAMar 26, 2024IL, NY• Baxter Healthcare Corporation

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Power Cords (Baxter) – Insulation Rating Problem (2024)

Spot Vision Screener (Baxter) – Power Cord Insulation Issue (2024)

Connex ProBP 3400 Device (Baxter) – Power Cord Insulation Issue (2024)

BiPAP V30 Ventilator (Philips) – Therapy Interruption Risk (2024)

BiPAP A40 Ventilator (Philips) – Therapy Interruption Risk (2024)

Stealth S8 Software (Medtronic) – Display Information Error (2024)

Rheo Knee 2 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

AW-M0001 Sonarmed Monitor (SonarMed) – Software Detection Failure (2024)

Rheo Knee XC 5 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

Rheo Knee XC 3 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

Rheo Knee 3 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

5000 Compact Series Ultrasound System (Philips) – Transducer Connection Error (2024)

Soft Suction Canister Liner (Medline) – Dimensional Variation (2024)

Redux Electrolyte Creme (Parker Laboratories) – Low Viscosity (2024)

Patient Information Center iX UPS (Philips) – Power Supply Failure (2024)

Med-Soft Single Liner with Solidifier (Medline) – Dimensional Variation (2024)

Med-Soft Liner with Tubing (Medline) – Dimensional Variation (2024)

OrthoPak Bone Growth Stimulator (EBI) – Lead Wire Damage (2024)

Soft Liner with Tubing (Medline) – Dimensional Variation (2024)

SpinalPak Spine Fusion Stimulator (EBI) – Lead Wire Damage (2024)