Philips Medical Systems recalled 810 Pinnacle Radiation Therapy Planning System units nationwide to healthcare providers. A software issue may cause an image error of the Region of Interest for HFP, FFS, and FFP orientations. Hospitals and clinics should stop using the software immediately and follow the manufacturer’s instructions.
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Medical Systems (Cleveland) Inc or your healthcare provider for instructions. Notification method: Letter
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Pinnacle3 is a radiation therapy planning software used to support treatment planning for disease processes using photon, electron, and brachytherapy techniques. It includes modules like Multimodality Simulation Workspace and Pinnacle TumorLOC.
The defect is a ROI image error during expansion/contraction for specific patient orientations. This may compromise dose calculations or treatment plan accuracy.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to halt certain planning activities until the software is corrected, potentially affecting scheduling and treatment planning integrity.
UDI codes and model numbers are listed in the recall notice and vendor communications. Healthcare providers should reference internal asset registers and procurement records.
Remediation timelines vary by facility; expect weeks for patches, verification, and validation.
Keep copies of the recall notice, correspondence with the vendor, patch notes, validation results, and any downtime records.
- Models: 870258, 870226, 870227, 870218, 870200 - Product: Pinnacle3 Radiation Therapy Planning System software with Multimodality Simulation Workspace 18.0.5; Pinnacle TumorLOC 16.2, 16.2.1, 16.0.2, 14.0 variants - Where sold: U.S. nationwide distribution to healthcare providers - When sold: Unknown - Price: Unknown - Quantity recalled: 810 (350 U.S. and 460 outside the U.S.)
No injuries or incidents have been reported.
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