Class II — Potential Health Hazard

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

Emission Computed Tomography System Image Process System - Product Usage: Recalled by Philips North America, LLC Due to A software defect that has the potential to...

Date: November 19, 2020
Company: Philips North America, LLC
Status: Terminated
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 North America, LLC directly.

Affected Products

Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Quantity: 2714

Why Was This Recalled?

A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America, LLC

Philips North America, LLC has 88 total recalls tracked by RecallDetector.

Related Recalls

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