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Latitude EV Humeral Revision Stem (Stryker) – Incorrect Part Marking (2025)

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

Moderate

FDAMar 3, 2025Nationwide• Tornier, Inc

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

Moderate

FDAFeb 28, 2025MN• Philips Medical Systems Nederland B.V. Veenpluis

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Latitude EV Humeral Revision Stem (Stryker) – Incorrect Part Marking (2025)

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)

Monterey AL Implant Inserter (Stryker) – Unlock Button Separation (2025)

Monterey AL Implant Inserter (Stryker) – Unlock Button Separation (2025)

Phoroptor VRx Digital Refraction System (Reichert) – Head Detachment Risk (2025)

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

t:slim X2 Insulin Pump (Tandem Diabetes) – Software Defect (2025)

NexGen LPS Flex Knee Joint (Zimmer) – Labeling Compatibility Error (2025)

Tandem Mobi Insulin Pump (Tandem Diabetes) – Software Defect (2025)

Access Vitamin B12 Reagent (Beckman Coulter) – Result Accuracy (2025)

MyDay Toric Contact Lenses (CooperVision) – Incorrect Cylinder Power (2025)

Solo Diamond Cone (Premier Dental) – Material Hardness Issue (2025)

Shiley Adult Tracheostomy Tube (Covidien) – Flange Disconnect Risk (2025)

Da Vinci 5 (Intuitive Surgical) – Foot Tray Pedal Failure (2025)

Hippo 072 Aspiration System (Qapel) – Catheter Tip Defect (2025)

DxC 500 AU Clinical Chemistry Analyzer (Beckman Coulter) – Software Defect (2025)

Nasopore Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

Nasopore Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

Zenition 70 (Philips) – Radiation Emission Risk (2025)

Nasopore Firm Nasal Dressing (Stryker) – Packaging Seal Issue (2025)