Philips Medical Systems (Cleveland) Inc: Device Recall

Recall #Z-2570-2025 · 08/05/2025

Class II: Risk

Recall Details

Recall Number
Z-2570-2025
Classification
Class II
Product Type
Device
Recalling Firm
Philips Medical Systems (Cleveland) Inc
Status
Ongoing
Date Initiated
08/05/2025
Location
Gainesville, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
810 (350 U.S. and 460 O.U.S.)

Reason for Recall

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.

Product Description

Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.

Distribution Pattern

U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

Other Recalls by Philips Medical Systems (Cleveland) Inc

View all recalls by Philips Medical Systems (Cleveland) Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.