CLASS II ONGOING Device recall · Reported 25 Sep 2024 · FDA Enforcement Report

System Name: 722044 Integris Allura recalled by Philips Medical Systems

Philips Medical Systems Nederl is recalling System Name: 722044 Integris Allura 15-12 (biplane) 722030 Integris CV, distributed nationwide in the US. The recall was initiated on 22 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C All serial numbers

Quantity recalled250 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-3167-2024
FDA event ID: 95256
Recalling firm: Philips Medical Systems Nederl, Best
Classification: Class II
Status: Ongoing
Recall initiated: 22 Aug 2024
FDA classified: 18 Sep 2024
Reported: 25 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

22 Aug 2024	Recall initiated by company
18 Sep 2024	Classified by FDA	+27 days
25 Sep 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

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C

Where it was distributed

Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Fiji Finland France French Polynesia Georgia Germany Ghana Gibraltar Greece Guadeloupe Guinea Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Libya Lithuania Macao Macedonia Malaysia Maldives Malta Martinique Mauritania Mauritius Mexico Mongolia Morocco Myanmar Nepal Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pakistan Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela Viet Nam Virgin Islands (U.S.) Yemen

Nationwide Georgia

Questions about this recall

Why was it recalled?

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

Which lots are affected?

Model Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C All serial numbers

Where was it sold?

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

3 other products · FDA event 95256

This product is part of a recall event; the main page for the event is System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 recalled.

Reported	Class	Recall	Company	Reason	Where
25 Sep 2024	CLASS II	System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 recalled	Philips Medical Systems Nederl	Foreign Material	Nationwide
25 Sep 2024	CLASS II	System Name: 722059 Allura Xper FD20/15 OR Table recalled	Philips Medical Systems Nederl	Foreign Material	Nationwide
25 Sep 2024	CLASS II	System Name: 708038 MultiDiagnost Eleva recalled	Philips Medical Systems Nederl	Foreign Material	Nationwide

More recalls from Philips Medical Systems Nederl

All 200

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay
19 Aug 2026Device	CLASS II	Allura Xper FD recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
12 Aug 2026Device	CLASS II	Philips Allura, Cardio Vascular-Allura Centron recalled	Philips Medical Systems Nederl	Other	Nationwide
24 Jun 2026Device	CLASS II	Philips Allura Xper with the following recalled	Philips Medical Systems Nederl	Other
24 Jun 2026Device	CLASS II	Philips MultiDiagnost Eleva with the following recalled	Philips Medical Systems Nederl	Other

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