CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Zenition 50 & 70 Mobile Surgery C-arm recalled by Philips North America

Philips North America is recalling Zenition 50 & 70 Mobile Surgery C-arm, distributed in Puerto Rico. The recall was initiated on 4 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesZenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824

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-0226-2024
FDA event ID: 93342
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Oct 2023
FDA classified: 9 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Oct 2023	Recall initiated by company
9 Nov 2023	Classified by FDA	+36 days
15 Nov 2023	Published in enforcement report	+6 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 become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Product as listed by the FDA

Zenition 50 & 70 Mobile Surgery C-arm

Where it was distributed

United States Territories of Puerto Rico, Guam, and Virgin Islands

Puerto Rico

Questions about this recall

Is Zenition 50 & 70 Mobile Surgery C-arm recalled?

Yes. Philips North America recalled Zenition 50 & 70 Mobile Surgery C-arm on 4 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0226-2024.

Why was it recalled?

Which lots are affected?

Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824

Where was it sold?

United States Territories of Puerto Rico, Guam, and Virgin Islands

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

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