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Use caution Medical device recall · FDA · Published November 20, 2019

Philips ProxiDiagnost N9: Increased Radiation Risk in Medical Imaging

Philips recalls ProxiDiagnost N90 medical imaging devices due to potential increased radiation exposure during scans. Affected units may require repair or replacement to ensure patient safety.

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

🇺🇸 FDA recall #Z-3023-2020Medical devicePhilips ›
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Contact the company

Recalling firmPhilips North America, LLC3000 Minuteman Rd · Andover, MA 01810-1032
✎ GovInfoNow plain-language explainer

Philips is recalling its ProxiDiagnost N90 medical imaging devices because they can increase radiation exposure to patients during scans. This could lead to higher radiation doses than intended, which may pose health risks. Read more at govinfonow.com/recall/66473-philips-proxidiagnost-n9-increased-radiation-risk-in-medical-imaging.

Source Summary by GovInfoNow · govinfonow.com/recall/66473-philips-proxidiagnost-n9-increased-radiation-risk-in-medical-imaging · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3023-2020

Cite this page

“Philips ProxiDiagnost N9: Increased Radiation Risk in Medical Imaging.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/66473-philips-proxidiagnost-n9-increased-radiation-risk-in-medical-imaging. Based on FDA recall #Z-3023-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3023-2020%22&limit=1).

The FDA announced on November 20, 2019, that Philips North America LLC is recalling the ProxiDiagnost N90. The device poses a hazard of unexpected increases in peak tube potential, leading to increased patient radiation doses.

How to tell if you have it

  • Brand: Philips
  • Product: ProxiDiagnost N90
  • Units affected: 71

The hazard

An unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent similar recalls include the Philips IQon Spectral CT Upgrades (June 11, 2026), the Philips MultiDiagnost Eleva Recall (May 18, 2026), and the Siemens ARTIS Pheno VE30A/VE40A (March 12, 2026).

How to tell if you have this one

Check if your medical imaging device is labeled as ProxiDiagnost N90. All units of this model are affected, regardless of when or where they were purchased.

  • Brand
    Philips
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Philips

    Reach out to Philips customer support to confirm if your device is affected and get instructions for repair or replacement.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.4 years after the firm started it.

1. Firm started the recall: Nov 20, 201912. FDA classified it Class II: Sep 30, 202023. Published in FDA’s Enforcement Report: Oct 7, 202034. FDA terminated the recall: Apr 4, 2024420192024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-3023-2020 (November 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3023-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA