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LOSPA Tibial Insert (Corentec) – Expiration Date Issue (2024)

Due to unsupported 10 year expiration date.

FDAMar 29, 2024Nationwide• CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)

Spectral CT Oncology Package (Philips) – Laser Marking Risk (2024)

Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.

Moderate

FDAMar 29, 2024Nationwide• Philips North America Llc

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LOSPA Tibial Insert (Corentec) – Expiration Date Issue (2024)

Spectral CT Oncology Package (Philips) – Laser Marking Risk (2024)

Dynamic Mesh Implant (Stryker) – Mislabeling Issue (2024)

RayStation 9.0 (RaySearch) – SSD Measurement Risk (2024)

Colorado Vehicle (Chevrolet) – Wheel Hub Bolt Issue (2024)

RayStation 12.0 (RaySearch) – SSD Measurement Risk (2024)

RayStation 8.1 (RaySearch) – SSD Measurement Risk (2024)

Intellis AdaptiveStim (Medtronic) – Reprogramming Limitation (2024)

NexGen CR-Flex Component (Zimmer) – Fixture Gap Issue (2024)

Fluorolog-QM Instrument (Horiba) – Laser Safety Defect (2024)

RayStation 10.0 (RaySearch) – SSD Measurement Risk (2024)

RayStation 8.0 (RaySearch) – SSD Measurement Risk (2024)

RayStation 11.0 (RaySearch) – SSD Measurement Risk (2024)

Cherokee Vehicle (Jeep) – Turn Signal Malfunction (2024)

G5 Transit Bus (Micro Bird) – Defroster System Failure (2024)

Forias Pack and Play Mattresses – Suffocation Risk (2024)

Snowmobiles with PATRIOT BOOST Engines (Polaris) – fire hazard (2024)

RayStation 15.0 (RaySearch) – SSD Measurement Risk (2024)

RayStation 13.0 (RaySearch) – SSD Measurement Risk (2024)

RayStation 9.1 (RaySearch) – SSD Measurement Risk (2024)