Reported Mar 16, 2022 · Ongoing
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized…
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 · N/A
Is this the product you have?
- ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
- Lot codes and dates
PAT.003 (KR)PAT.006 (US)PAT.107 (EU)PAT.108 (US)PAT109 (US)PAT.110 (US)PAT.111 (EU)PAT.112 (US)PAT.113 (US)PAT.114 (EU)PAT.115 (EU)SAT.116 (US)SAT.117 (EU)SAT.118 (RU)SAT.119 (US)SAT.120 (EU)SAT.122 (EU)SAT.123 (US)SAT.125 (IN)SAT.126 (US)SAT.127 (TW)SAT.132 (EU)SAT.133 (US)SAT.136 (IN)SAT.140 (US)SBF.101 (EU)SBF.103 (JP)SBF.104 (JP)SBF.105 (US)SBF.107 (FR)SBF.109 (UK)SBF.110 (UK)SBF.112 (EU)SBF.113 (US)SBF.115 (UK)SBF.117 (EU)SBF.128 (US)
- UDI(01)05404013801138
- Amount recalled
- 15 units US; 22 units OUS
Where it was sold
Why it was recalled
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
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 infant & baby 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.