Philips Medical Systems (Cleveland) Inc has recalled 149 serial numbers of its Pinnacle 3 with TumorLOC (870258) Radiation Therapy Planning System Software, version 18.0.5. The recall was initiated because a software issue can cause the system to provide incorrect calculations for the "Stopping Power Ratio" (SPR) when planning treatments. Healthcare providers should contact the manufacturer for instructions on how to handle affected systems.
The software defect may lead to incorrect dataset calculations, which could cause patients to receive inaccurate radiation doses during therapy, potentially resulting in serious medical complications or ineffective treatment.
Quantity affected: 149 Serial Numbers.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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