Summary
The FDA issued a Class II for Proteus 235; Version: PTS-8 versions before PTS-8.7.2 by Ion Beam Applications S.A.. Reason: Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test en.
Details
Source
Device Recall
External ID
Z-0466-2022
Action Date
2022-01-19
Status
Terminated
Category
device
Product Description
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Lot/Code Info: PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).
Quantity Affected: 5 devices
Reason for Recall
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
Distribution
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-29
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 106 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-0466-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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