Reported Jun 28, 2017 · Terminated
Proteus 235
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin du Cyclotron, 3 · Louvain La Neuve · N/A
Is this the product you have?
- Proteus 235
- Lot codes and dates
- Serial Numbers
PAT.000PAT.003PAT.006PAT.107PAT.108PAT.109PAT.111PAT.112PAT.113PAT.114SAT.115SAT.116SAT.117SAT.119SAT.120SAT.122SAT.123SAT.126
- Serial Numbers
- Amount recalled
- 18 systems ( 10 in the US)
Where it was sold
Why it was recalled
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ion Beam Applications S.A. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.