Lower risk Medical device recall · FDA · Published March 3, 2023

Philips ProxiDiagnost N90 R.1.0 Missing FDA Certification Label

Philips recalls ProxiDiagnost N90 R.1.0 devices missing FDA certification labels. Affected units may not meet regulatory standards. Consumers should check serial numbers listed in the recall notice.

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

🇺🇸 FDA recall #Z-1587-2023Medical device Philips ›

Lower-risk recall

Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Take action

Contact the company

Recalling firmPhilips North America222 Jacobs St · Cambridge, MA 02141-2296

✎ GovInfoNow plain-language explainer

Philips is recalling specific models of ProxiDiagnost N90 R.1.0 devices that lack an FDA certification label. This issue means the devices might not meet regulatory standards, but it does not pose a direct safety risk to users. Read more at govinfonow.com/recall/58790-philips-proxidiagnost-n90-r-1-0-missing-fda-certification-label.

Source Summary by GovInfoNow · govinfonow.com/recall/58790-philips-proxidiagnost-n90-r-1-0-missing-fda-certification-label · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1587-2023

Cite this page

“Philips ProxiDiagnost N90 R.1.0 Missing FDA Certification Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58790-philips-proxidiagnost-n90-r-1-0-missing-fda-certification-label. Based on FDA recall #Z-1587-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1587-2023%22&limit=1).

The FDA announced on March 3, 2023, that Philips North America is recalling ProxiDiagnost N90 R.1.0 systems because they are missing a required certification label. The agency classified the recall as Class II.

How to tell if you have it

Brand: Philips
Product: ProxiDiagnost N90 R.1.0
REF number: 706100
Serial numbers: 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067
Quantity: 25 systems

The hazard

The ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).

Context

GovInfoNow's records show Philips North America has 30 other recalls on record since December 24, 2020. Other recent recalls of similar products include Evolution upgrade 1.5T amd Evolution upgrade 3.0T (August 28, 2026), Patient Information Center iX Software Freezes (July 31, 2026), and SmartPath to dStream for XR and 3.0T MRE Devices May Have Stiffness Errors (April 14, 2026).

How to tell if you have this one

Check if your device has a serial number listed in the recall notice: 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, or 20000067.

Brand
Philips
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide

Recall number	Product, codes & lots
Z-1587-2023	ProxiDiagnost N90 R.1.0; REF number 706100 Serial number 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067.
Z-1588-2023	CombiDiagnost R90 R.1.0; REF number 709030 Serial number 10001076
Z-1589-2023	CombiDiagnost R90 R1.1; REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for the serial number on your device to see if it matches the list provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

Mar 3, 2023Firm started the recall
May 15, 2023FDA classified it Class II
May 24, 2023Published in FDA’s Enforcement Report

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/58790-philips-proxidiagnost-n90-r-1-0-missing-fda-certification-label">Philips ProxiDiagnost N90 R.1.0 Missing FDA Certification Label (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-1587-2023 (March 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1587-2023 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.