Z-2587-2023Class II

Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

Name: Z-2587-2023 Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Creator: Philips Medical Systems Nederland B.v.
Published: 2023-08-15
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-08-15 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems on 2023-08-15. FDA classified it as Class II and gives the reason as "A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2587-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-15
Posted: 2023-09-14
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Root cause tag: design
FDA root cause: Device Design
Action: US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to provide an IFU Addendum.
Quantity in commerce: 19,115 systems
Distribution: Worldwide distribution
Product codes and lots: Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2587-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2587-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-14

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)