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August 1, 2025
Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/1/2025 Class: II PRODUCT Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Recall Number: Z-2239-2025 REASON: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the “Stopping Power Ratio” (SPR) , RECALLING FIRM/MANUFACTURER: Philips Medical Systems (Cleveland)...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

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