CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report

CombiDiagnost R90 1.0 (709030) recalled by Philips Medical Systems

Philips Medical Systems is recalling CombiDiagnost R90 1.0 (709030), distributed nationwide in the US. The recall was initiated on 11 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: R90 1.0 (709030); UDI DI: 00884838076747; Software version 1.1.1 or higher; Serial numbers: 10000000, 10000002, 10000003, 10000004, 10000006, 10000011, 10000012, 10000020, 10000024, 10000027, 10000049, 10000050, 10000065, 10000066, 10000067, 10000069, 10000078, 10000081, 10000099, 10000103, 10000107, 10000140, 10000145, 10000152, 10000180, 10001001, 10001010, 10001095, 591362, SN16000009, SN17000003, SN17000007, SN17000015, SN17000022, SN17000111, SN17000114, SN17000118, SN17000120, SN17000121, SN17000122, SN17000123, SN17000128, SN17000129, SN17000130, SN17000145, SN17000146, SN17000147, SN17000148, SN17000153, SN17000157, SN17000163, SN17000165, SN17000166, SN18000003, SN18000004, SN18000010, SN18000021, SN18000025, SN18000033, SN18000037, SN18000038, SN18000044, SN18000045, SN18000053, SN18000054, SN18000057, SN18000060, SN18000068, SN18000069, SN18000079, SN19000004, SN19000006, SN19000011, SN19000020, SN19000034, SN19000036, 27, 40, 41, 42, 77, 101, 131, 155, 180, 190;

Quantity recalled86 units

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-1087-2024
FDA event ID: 93819
Recalling firm: Philips Medical Systems, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Feb 2022
FDA classified: 14 Feb 2024
Reported: 21 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Feb 2022	Recall initiated by company
14 Feb 2024	Classified by FDA	+733 days
21 Feb 2024	Published in enforcement report	+7 days

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

Reason for recall

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

Product as listed by the FDA

CombiDiagnost R90 1.0 (709030)

Where it was distributed

US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

Nationwide California Florida Georgia Illinois Indiana Kansas Maryland Maine Michigan Minnesota North Carolina New Jersey New York Texas Virginia Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Model: R90 1.0 (709030); UDI DI: 00884838076747; Software version 1.1.1 or higher; Serial numbers: 10000000, 10000002, 10000003, 10000004, 10000006, 10000011, 10000012, 10000020, 10000024, 10000027, 10000049, 10000050, 10000065, 10000066, 10000067, 10000069, 10000078, 10000081, 10000099, 10000103, 10000107, 10000140, 10000145, 10000152, 10000180, 10001001, 10001010, 10001095, 591362, SN16000009, SN17000003, SN17000007, SN17000015, SN17000022, SN17000111, SN17000114, SN17000118, SN17000120, SN17000121, SN17000122, SN17000123, SN17000128, SN17000129, SN17000130, SN17000145, SN17000146, SN17000147, SN17000148, SN17000153, SN17000157, SN17000163, SN17000165, SN17000166, SN18000003, SN18000004, SN18000010, SN18000021, SN18000025, SN18000033, SN18000037, SN18000038, SN18000044, SN18000045, SN18000053, SN18000054, SN18000057, SN18000060, SN18000068, SN18000069, SN18000079, SN19000004, SN19000006, SN19000011, SN19000020, SN19000034, SN19000036, 27, 40, 41, 42, 77, 101, 131, 155, 180, 190;

Where was it sold?

US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

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

1 other product · FDA event 93819

This product is part of a recall event; the main page for the event is CombiDiagnost R90 1.1 (709031) recalled by Philips Medical Systems.

Reported	Class	Recall	Company	Reason	Where
21 Feb 2024	CLASS II	CombiDiagnost R90 1.1 (709031) recalled by Philips Medical Systems	Philips Medical Systems	Other	Nationwide

More recalls from Philips Medical Systems

All 82

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled	Philips Medical Systems	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	IQon Spectral CT IQon Spectral CT Upgrades recalled	Philips Medical Systems	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	Philips Spectral CT on Rails recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide