Quick Facts at a Glance
- Recall Date
- August 5, 2025
- Hazard Level
- HIGH
- Brand
- Philips Medical Systems
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips Medical Systems
- Product type
- Pinnacle3 Radiation Therapy Planning System software
- Model numbers
- 870258, 870226, 870227, 870218, 870200
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 5, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
The defect is a ROI image error during expansion/contraction for specific patient orientations. This may compromise dose calculations or treatment plan accuracy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt certain planning activities until the software is corrected, potentially affecting scheduling and treatment planning integrity.
Practical Guidance
How to identify if yours is affected
- Review UDI codes if available in the recall documentation
- Check for recall notification letters and vendor updates on ROI-related patches or fixes
Where to find product info
UDI codes and model numbers are listed in the recall notice and vendor communications. Healthcare providers should reference internal asset registers and procurement records.
What timeline to expect
Remediation timelines vary by facility; expect weeks for patches, verification, and validation.
If the manufacturer is unresponsive
- Escalate to hospital compliance or biomedical engineering
- Contact your equipment vendor’s support line via official channels
- If needed, file a consumer safety complaint with the appropriate agency
How to prevent similar issues
- Implement formal software validation and ROI verification steps after patches
- Maintain an auditable change log for planning software
- Confirm with the vendor before deploying plan changes
- Keep vendor contact information and recall notices accessible
Documentation advice
Keep copies of the recall notice, correspondence with the vendor, patch notes, validation results, and any downtime records.
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Product Details
- 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.)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 810 total units recalled
- 350 U.S. units, 460 outside U.S.
- Hazard: ROI image error for HFP, FFS, FFP orientations
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Safety Guide
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