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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
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.
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.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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.
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
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
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.
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
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.
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
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.
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.
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.