CLASS II ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report

CombiDiagnost R90 R1.1 recalled by Philips North America

Philips North America is recalling CombiDiagnost R90 R1.1, distributed nationwide in the US. The recall was initiated on 3 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Quantity recalled25 systems in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1589-2023
FDA event ID: 92333
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2023
FDA classified: 15 May 2023
Reported: 24 May 2023
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Mar 2023	Recall initiated by company
15 May 2023	Classified by FDA	+73 days
24 May 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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).

Product as listed by the FDA

CombiDiagnost R90 R1.1

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Where was it sold?

US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 92333

This product is part of a recall event; the main page for the event is ProxiDiagnost N90 R.1.0 recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
24 May 2023	CLASS II	ProxiDiagnost N90 R.1.0 recalled by Philips North America	Philips North America	Other	Nationwide
24 May 2023	CLASS II	CombiDiagnost R90 R.1.0 recalled by Philips North America	Philips North America	Other	Nationwide

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