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Showing 2921–2940 of 22584 results

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

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

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

Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

FDAMay 31, 2024Nationwide• Stryker Sustainability Solutions

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

Fire/Burn Risk

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

High

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

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

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

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

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

FDAMay 31, 2024Nationwide• Avanos Medical, Inc.

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

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.

FDAMay 31, 2024Nationwide• Maquet Cardiovascular, LLC

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

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

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

There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.

FDAMay 31, 2024Nationwide• Maquet Cardiovascular, LLC

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

Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

FDAMay 31, 2024Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

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

There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.

FDAMay 31, 2024Nationwide• Smiths Medical ASD Inc.

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

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

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

Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury

FDAMay 30, 2024Nationwide• Dental EZ Group Star Dental Division

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

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

FDAMay 30, 2024Nationwide• Baxter Healthcare Corporation

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

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

FDAMay 30, 2024Nationwide• Baxter Healthcare Corporation

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

Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury

FDAMay 30, 2024Nationwide• Dental EZ Group Star Dental Division

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

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

FDAMay 29, 2024Nationwide• Smiths Medical ASD Inc.

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

Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.

FDAMay 29, 2024Nationwide• Baxter Healthcare Corporation

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

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

FDAMay 29, 2024Nationwide• Integra LifeSciences Corp.

ALPHAMAXX Mobile Operating Table (Getinge) – Charger Defect (2024)

The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.

FDAMay 29, 2024KY, NY, NC +1 more• Getinge Usa Sales Inc

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

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

FDAMay 29, 2024Nationwide• Cardinal Health 200, LLC

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