Pinnacle 3 radiation planning software may miscalculate stopping power ratio
Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.
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 3/5 (High).
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: Risk-of-harm product: incorrect calculations in software used to plan radiation therapy, with no patient harm reported in the source.
Plain-English summary
Pinnacle 3 with TumorLOC (870258) Radiation Therapy Planning System software, software version 18.0.5, UDI 00884838103566, is being recalled. The action covers 149 serial numbers.
The stated reason is that, due to a software issue, the Radiation Therapy Planning system may provide incorrect dataset calculations when performing the Stopping Power Ratio. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was worldwide, including nationwide in the United States in West Virginia and to other countries. The software is used by healthcare facilities rather than sold to consumers.
Facilities should identify affected installations using the software version and UDI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 149
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 Number: 18.0.5/UDI: (01)00884838103566
Distribution
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