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Soltive Pro Laser (Olympus) – Non-Compliant Power Cord (2024)

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

Low

FDAJan 29, 2024IN• Olympus Corporation of the Americas

Embrace Drill Tower (Waldemar Link) – Technique Description Mix-up (2024)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Low

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

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Soltive Pro Laser (Olympus) – Non-Compliant Power Cord (2024)

Embrace Drill Tower (Waldemar Link) – Technique Description Mix-up (2024)

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Vantage Elan MRI (Canon) – SFG Value Mismatch (2024)

Soltive Laser (Olympus) – Non-Compliant Power Cord (2024)

Vantage Titan MRI (Canon) – SFG Value Mismatch (2024)

NxStage Cartridge Express (NxStage) – Blood Leakage Risk (2024)

VITROS 5600 System (Ortho) – QC Baseline Defect (2024)

BCID2 Panel (BioFire) – False Positive Results (2024)

VITROS 3600 System (Ortho) – QC Baseline Defect (2024)

I.B.S Compression Screw (In2Bones) – Batch Mix-up (2024)

FilmArray GI Panel (BioFire) – False Norovirus Results (2024)

Schiff Reagent (EMD Millipore) – Unexpected Color (2024)

VITROS XT 3400 System (Ortho) – QC Baseline Defect (2024)

IdentiTi ALIF System (Alphatec) – Graft Bolt Breakage (2024)

VITROS 4600 System (Ortho) – QC Baseline Defect (2024)

VITROS XT 7600 System (Ortho) – QC Baseline Defect (2024)

SW Bari Lift (Raye's) – Hoist Performance Issue (2024)

Ionolux (Voco) – Plunger Fitting Error (2024)

IonoStar Plus (Voco) – Plunger Fitting Error (2024)