Z-2155-2021 Class II Ongoing
FDA device recall Z-2155-2021 was initiated by Ion Beam Applications S.A. on May 26, 2021 and is designated Class II. Reason for recall: 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 prescrib… The recall status is ongoing. Affected quantity: 5 US; 8 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- May 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 US; 8 OUS
Product Description
Proteus 235-Proton Therapy System
Reason for Recall
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
Distribution Pattern
FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Code Information
Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).