Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2025 - (Recall #: Z-2239-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software

Product Classification:

Class II

Date Initiated: July 17, 2025

Date Posted: August 13, 2025

Recall Number: Z-2239-2025

Event ID: 97309

Reason for Recall:

Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

Status: Ongoing

Product Quantity: 149 Serial Numbers

Code Information:

Software Version Number: 18.0.5/UDI: (01)00884838103566

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated