Reported Jan 20, 2021 · Terminated

Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Emission Computed Tomography System
  • Image Process System - Product Usageintended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body
Lot codes and dates
    • Model# 882310
    • 882311
    • 882313 All Lots
Amount recalled
2714

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 19, 2023 · Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.