Radiation planning software recalled over image errors in three patient orientations
Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an image error in treatment planning could affect the region targeted, and no injuries are reported.
Plain-English summary
The Pinnacle Radiation Therapy Planning System is being recalled across Multimodality Simulation Workspace 18.0.5, model 870258, and Pinnacle TumorLOC 16.2, model 870226, along with the further versions listed in the recall notice. The recall covers 810 installations, of which 350 are in the United States and 460 outside it.
Because of a software issue, there is a potential image error of the Region of Interest for expansion or contraction in head first prone (HFP), feet first supine (FFS) and feet first prone (FFP) orientations. The FDA classified the action as Class II.
Radiotherapy centres running these versions should follow the manufacturer's instructions for the software correction.
The recalled product
- Product
- Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
Distribution
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