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Philips SENSE XL Torso Coil (Philips) – Patient Burn Risk (2024)

Fire/Burn Risk

Potential for coils to heat up and harm patients (burn).

High

FDAJun 5, 2024Nationwide• Philips North America Llc

Synergetics I Pack Injection Kit (MICROspecialties) – Sterilization Concern (2024)

Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

High

FDAJun 5, 2024MO• MICROspecialties, Inc.

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Philips SENSE XL Torso Coil (Philips) – Patient Burn Risk (2024)

Synergetics I Pack Injection Kit (MICROspecialties) – Sterilization Concern (2024)

Philips SENSE XL Torso Coil (Philips) – Patient Burn Risk (2024)

Philips SENSE XL Torso Coil Mk2 (Philips) – Patient Burn Risk (2024)

iLED 7 Surgical Lights (Baxter) – Thermal Injury Risk (2024)

Zyno Medical Infusion Pumps (Zyno Medical) – Power Supply Failure (2024)

Beckman Coulter DXL 9000 Analyzer (Beckman Coulter) – Cable Corrosion Risk (2024)

Trulight 5000/3000 Surgical Light (Baxter) – Thermal Injury Risk (2024)

VidiaPort Carrying Arm (Baxter) – Thermal Injury Risk (2024)

Meridian Angled Awl (SeaSpine) – Insufficient Weld (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Welch Allyn CP150 Electrocardiograph (Baxter) – EMI Absorber Missing (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Bottle Decanter (Microtek Medical) – Packaging Integrity Issue (2024)

Stryker Flyte Hood (Stryker) – Expired Product (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

QIAcube Connect MDx (Qiagen) – Heater Shaker Malfunction (2024)

Nalu Neurostimulation Kit (Nalu Medical) – Signal Efficiency Problem (2024)

Fresenius Blood Pump Rotor (Fresenius) – Dislodgement Risk (2024)

Stryker Single Use Device (Stryker) – Expired Product (2024)