Philips Pinnacle3 Radiation Therapy Planning System Software Recall
Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.
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 involves a medical device defect that can cause incorrect beam geometry in radiation therapy, which poses a risk of harm to patients. The source text does not report any specific injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland), Inc. is recalling the Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. The recall involves units manufactured between September 29, 2009, and December 1, 2013.
The recall was initiated because Philips determined that a software nonconformance can cause incorrect beam geometry. This defect affects the planning of radiation therapy treatments.
The affected software was distributed worldwide, including in the United States and various international locations. The source text does not specify the total number of affected units or provide specific instructions for consumers or healthcare providers on how to proceed.
The recalled product
- Product
- Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
- Affected units
- 1,016
Distribution
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