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Soltive Laser Wireless Footswitch (Olympus) – Pairing Problem (2024)

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

FDAMay 31, 2024Nationwide• Olympus Corporation of the Americas

paraPAC Plus 310 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

High

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

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Soltive Laser Wireless Footswitch (Olympus) – Pairing Problem (2024)

paraPAC Plus 310 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

AXIOM Vertix MD (Siemens) – Fire Hazard (2024)

Zimmer Tourniquet Cuff (Stryker) – Mislabeling Issue (2024)

MULTIX TOP X-ray Table (Siemens) – Fire Hazard (2024)

AXIOM MULTIX MP X-ray Table (Siemens) – Fire Hazard (2024)

MIC-KEY Feeding Tube Kit (Avanos) – Incomplete Risk Information (2024)

VASOVIEW HEMOPRO 2 Vessel Harvesting System (Maquet) – C-Ring Wire Problem (2024)

AXIOM Vertix Solitaire (Siemens) – Fire Hazard (2024)

VASOVIEW HEMOPRO Vessel Harvesting System (Maquet) – C-Ring Wire Problem (2024)

ABL800 FLEX Analyzer (Radiometer) – Calibration Solution Issue (2024)

Pneupac paraPAC Plus 310 Ventilator (Smiths Medical) – Tidal Volume Knob Risk (2024)

AXIOM MULTIX MT X-ray Table (Siemens) – Fire Hazard (2024)

T-MALE Testosterone Support (NaturesPlus) – ingredient mismatch (2024)

Ultra T-MALE Testosterone Boost (NaturesPlus) – ingredient mismatch (2024)

Titan Blis-Sonic Scaler (Dental EZ Group) – Tip Seating Issue (2024)

Volara System Circuit (Baxter) – Handset Plug Disconnect (2024)

Volara System Blue Ventilator Adapter (Baxter Healthcare) – Disconnection Risk (2024)

Titan Scaler Tip - Perio (Dental EZ Group) – Tip Seating Problem (2024)

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)