Philips Pinnacle3 Radiation Treatment Planning Software Recalled for Dose Inconsistency
Philips is recalling Pinnacle3 Radiation Treatment Planning System software versions 8.0 and 9.0 due to potential dose inconsistencies with density-overridden ROIs.
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: The recall is classified as FDA Class II. The hazard involves potential dose inconsistency in radiation treatment planning, which is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling Pinnacle3 Radiation Treatment Planning System software, including versions 8.0h, 8.0k, 8.0m, 8.0n, 9.0, 9.2, 9.4, and 9.6. The recall involves 1,642 units distributed worldwide, including all US states, DC, Puerto Rico, and numerous international locations.
The recall was initiated because the radiation dose may be inconsistent with the density of a density-overridden Region of Interest (ROI). This software is used in medical settings to plan radiation treatments for patients.
Healthcare facilities and users of the affected software should contact Philips for instructions on how to address the issue. The source text does not specify a particular action for consumers, as this is a professional medical device software recall.
The recalled product
- Product
- Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 1,642
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 (5)
- 453560446041
- 459800091001
- 459800220161
- 459800232931
- 459800235871
Distribution
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