CLASS II ONGOING Device recall · Reported 13 Sep 2023 · FDA Enforcement Report

Allura Xper series recalled by Philips Medical Systems

Philips Medical Systems Nederl is recalling Allura Xper series, distributed nationwide in the US. The recall was initiated on 19 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAllura Xper series

Quantity recalled5432 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-2402-2023
FDA event ID: 92855
Recalling firm: Philips Medical Systems Nederl, Eindhoven, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 19 Jul 2023
FDA classified: 7 Sep 2023
Reported: 13 Sep 2023
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Jul 2023	Recall initiated by company
7 Sep 2023	Classified by FDA	+50 days
13 Sep 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

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Product as listed by the FDA

Allura Xper series

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Which lots are affected?

Allura Xper series

Where was it sold?

US Nationwide Distribution

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 92855

Reported	Class	Recall	Company	Reason	Where
13 Sep 2023	CLASS II	Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide
13 Sep 2023	CLASS II	MultiDiagnost-Eleva recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	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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