Philips Proton Therapy Planning Software Recalled for Dose Calculation Errors
Philips Medical Systems is recalling DS/US Proton Feature software due to a defect that may cause incorrect dose calculations in radiation therapy planning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect in a medical device that can result in incorrect dose calculations for radiation therapy, which poses a significant risk of injury to patients.
Plain-English summary
Philips Medical Systems is recalling the DS/US Proton Feature with Pinnacle3 Software, versions 10.0.0 and 14.0.0, for the Radiation Therapy Planning System Model #459800200621. The recall involves three units distributed nationwide in Florida, Ohio, and Missouri.
The recall is being issued because a correction factor used internally by the dose engine is calculating improperly in some cases. This defect can result in an incorrect dose calculation during proton planning.
Healthcare facilities that have purchased or are using this specific software version should contact Philips Medical Systems for further instructions on how to address the issue.
The recalled product
- Product
- DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
- Manufacturer
- Philips Medical Systems
- Affected units
- 3
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 (1)
- Software Version 10.0.0 and 14.0.0
Distribution
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