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Other Medical Devices

🏥 Medical Devices 15,809 recalls

Proteus 235-Proton Therapy System

Ion Beam Applications S.A.

Class I - Dangerous

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

May 26, 2021 Other Medical Devices View Details →

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

Jul 14, 2021 Other Medical Devices View Details →

Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

Jun 8, 2021 Other Medical Devices View Details →
Class I - Dangerous

Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.

May 25, 2021 Other Medical Devices View Details →

Potential for mold contamination (Aspergillus vadensis)

May 25, 2021 Other Medical Devices Nationwide View Details →