Lower risk Medical device recall · FDA · Published November 19, 2020

Philips Emission CT Image Processor Recall: Risk of Image Misdiagnosis

Philips recalls certain Emission Computed Tomography Image Process Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment. Affected models include 882310, 882311, and 882313.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0852-2021Medical device Philips ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmPhilips North America, LLC3000 Minuteman Rd · Andover, MA 01810-1032

✎ GovInfoNow plain-language explainer

Philips is recalling specific Emission Computed Tomography Image Process Systems that could cause image misdiagnosis and incorrect patient treatment due to a software defect. This affects medical imaging equipment used in nuclear medicine procedures. Read more at govinfonow.com/recall/63843-philips-emission-ct-image-processor-recall-risk-of-image-misdiagnosis.

Source Summary by GovInfoNow · govinfonow.com/recall/63843-philips-emission-ct-image-processor-recall-risk-of-image-misdiagnosis · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0852-2021

Cite this page

“Philips Emission CT Image Processor Recall: Risk of Image Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63843-philips-emission-ct-image-processor-recall-risk-of-image-misdiagnosis. Based on FDA recall #Z-0852-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0852-2021%22&limit=1).

The FDA announced on 2020-11-19 that Philips North America, LLC is recalling its Emission Computed Tomography System Image Process Systems due to a software defect that could lead to image misdiagnosis and incorrect patient treatment. The agency classified the recall as Class II.

How to tell if you have it

Brand: Philips
Product: Emission Computed Tomography System Image Process System
Model Numbers: 882310, 882311, 882313
Lots: All Lots

The hazard

According to the FDA, a software defect in the system has the potential to result in image misdiagnosis and incorrect treatment of a patient. The device is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Context

GovInfoNow's records show Philips North America Llc has issued 129 other recalls since 2017-07-12. Recent recalls include the Ingenia 3.0T and Ingenia 3.0T CX (2026-08-21), the Spectral CT 7500 Scanner (2026-08-18), and the Brilliance CT 64 Medical Scanner (2026-08-07). Other recent recalls of similar products include the Philips Spectral CT 7500 RT Software Issues May Cause Image Artifacts (2026-08-21), the Philips Incisive CT Recall: Unstable Sensor May Cause Incomplete Scans (2025-12-03), and the Philips Azurion System Software R3.1 May Cause Imaging Loss - Recall (2025-12-12).

How to tell if you have this one

Check if your Philips Emission Computed Tomography Image Process System has model numbers 882310, 882311, or 882313. All lots of these models are affected by the recall.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Identify the model number on your Philips Emission Computed Tomography Image Process System to confirm if it is affected (882310, 882311, or 882313).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Finland, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Nov 19, 2020Firm started the recall
Jan 13, 2021FDA classified it Class II
Jan 20, 2021Published in FDA’s Enforcement Report
Apr 19, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63843-philips-emission-ct-image-processor-recall-risk-of-image-misdiagnosis">Philips Emission CT Image Processor Recall: Risk of Image Misdiagnosis (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0852-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0852-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.