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Fuse ULTRA Foot Plating System (CPM Medical) – Sterilization Update (2025)

Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

Moderate

FDASep 17, 2025Nationwide• CPM Medical Consultants, LLC.

SYNCHRON LDL Cholesterol Reagent (Beckman Coulter) – Test Accuracy Issue (2025)

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

Moderate

FDASep 17, 2025Nationwide

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Fuse ULTRA Foot Plating System (CPM Medical) – Sterilization Update (2025)

SYNCHRON LDL Cholesterol Reagent (Beckman Coulter) – Test Accuracy Issue (2025)

InSure ONE Test (Enterix) – False Negative Risk (2025)

Oral Probe (Baxter) – Temperature Reading Error (2025)

BrainSTORM Surgical Planner (Surgical Theater) – Image Alignment Issue (2025)

SyncAR Surgical Navigation (Surgical Theater) – Image Fusion Misalignment (2025)

SpineAR Surgical Navigation (Surgical Theater) – Image Fusion Problem (2025)

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Surgical Navigation Platform (Surgical Theater) – Image Misalignment Risk (2025)

Impella Controller (Abiomed) – Purge Pressure Problem (2025)

Surgical Planner (Surgical Theater) – Image Fusion Misalignment (2025)

Endo Surgical Navigation (Surgical Theater) – Image Fusion Misalignment (2025)

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

CONSTELLATION Ultrasound (Alcon) – Unspecified Issue (2025)

Galaxy System (Noah Medical) – Manual Access Problem (2025)

Millenium MPR (GE Medical) – Service End Risk (2025)

Sopha Medical Vision (GE Medical) – Service End Risk (2025)

Elscint SPX6 (GE Medical) – Service End Risk (2025)

Maxicam (GE Medical) – Service End Risk (2025)