Summary
The FDA issued a Class II for Proteus 235-Proton Therapy System by Ion Beam Applications S.A.. Reason: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered wi.
Details
Source
Device Recall
External ID
Z-2155-2021
Action Date
2021-08-04
Status
Ongoing
Category
device
Product Description
Proteus 235-Proton Therapy System
Lot/Code Info: 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).
Quantity Affected: 5 US; 8 OUS
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
FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-26
Company
Louvain-la-neuve, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ion Beam Applications S.A. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ion Beam Applications S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ion Beam Applications S.A. have FDA actions?
Ion Beam Applications S.A. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2155-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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