Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Pinnacle3 Radiation Therapy Planning System Recalled by Philips Medical Systems (Cleveland) Inc Due to When computing a radiation dose in the system,...

Date: August 30, 2022
Company: Philips Medical Systems (Cleveland) Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.

Affected Products

Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Quantity: 169 systems

Why Was This Recalled?

When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

Where Was This Sold?

This product was distributed to 21 states: CA, FL, GA, IL, IA, ME, MD, MA, MI, MN, NV, NJ, NM, NY, OH, OK, RI, SC, TN, TX, WA

Affected (21 states)Not affected

About Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report