IBA Proton Therapy System Patient Positioning Can Move Unexpectedly
The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a proton therapy medical device where the patient positioning system can perform unexpected motions with potential for patient crushing. No incidents or injuries have been reported. Per the recall severity rubric, this constitutes a risk-of-harm product where injury has not been reported, warranting a High (3) severity rating.
Plain-English summary
The FDA is recalling the IBA Proton Therapy System PROTEUS 235, configured with the Orion Patient Positioning System. This medical device is used for proton beam cancer treatment.
The patient positioning system can perform motions in unexpected directions, creating potential for patient crushing between the positioning devices. This poses a patient safety risk.
Five units are distributed in the US (Arkansas, Florida, Kansas, and Virginia), and nine units are distributed internationally (Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan). Specific serial numbers of affected units are available from the FDA.
Healthcare facilities operating equipment with the listed serial numbers should contact Ion Beam Applications S.A. regarding remediation.
The recalled product
- Product
- IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
- Manufacturer
- Ion Beam Applications S.A.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI-DI: (01)05404013801138. Serial numbers (US): SAT133
- SAT140
- SBF113
- SBF128
- SBF135 & (OUS): SAT125
- SAT127
- SAT132
- SAT136
- SBF107
- SBF112
- SBF117
- SBF124
- & SBF125.
Distribution
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