HIGH

Philips Medical Systems Recalls Radiation Therapy Planning Software

Philips Medical Systems recalled 810 units of its Radiation Therapy Planning System on August 5, 2025. A software issue may cause image errors during treatment planning. Affected models include Pinnacle TumorLOC and Multimodality Simulation Workspace.

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

Product Details

The recall affects the Pinnacle Radiation Therapy Planning System, including models 870258, 870226, 870227, 870218, and 870200. These devices were distributed nationwide in the U.S. and internationally. Prices for these systems vary based on the model.

The Hazard

Due to a software issue, there is a potential image error of the Region of Interest for expansion and contraction for specific patient orientations. This could lead to improper treatment planning.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The software's failure may compromise patient safety during radiation therapy.

What to Do

Stop using the affected devices immediately. Follow the recall instructions provided by Philips Medical Systems and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Philips Medical Systems at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2570-2025.

Key Facts

  • 810 units recalled
  • Potential image errors in treatment planning
  • Stop using the device immediately
  • Contact Philips Medical Systems for instructions
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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
870258
870226
870227
870218
870200
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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