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Soltive Pro Laser System (Olympus) – Footswitch Pairing Issue (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 300 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 Pro Laser System (Olympus) – Footswitch Pairing Issue (2024)

paraPAC 300 Ventilator (Smiths Medical) – Connector Detachment Risk (2024)

Soltive Premium Laser System (Olympus) – Footswitch Pairing Issue (2024)

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

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

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

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

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

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

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

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

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

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

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

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

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

PORTEX Bivona Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

Life2000 Ventilator (Baxter Healthcare) – Battery Charging Failure (2024)

Presource Kits (Cardinal Health) – FDA Disposition Concern (2024)

CUSA Excel Handpiece (Integra LifeSciences) – Housing Crack Risk (2024)