Proteus 235-Proton Therapy System
Reported: August 4, 2021 Initiated: May 26, 2021 #Z-2155-2021
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
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 5 US; 8 OUS
- Distribution
- FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
- Location
- Louvain-la-neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
Proteus 235-Proton Therapy System. Recalled by Ion Beam Applications S.A.. Units affected: 5 US; 8 OUS.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 4, 2021. Severity: Moderate. Recall number: Z-2155-2021.
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