Z-2893-2026Class II

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System

Name: Z-2893-2026 Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System
Creator: Philips Medical Systems Nederland B.v.
Published: 2026-06-17
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2026-06-17 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System on 2026-06-17. FDA classified it as Class II and gives the reason as "Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2893-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-17
Posted: 2026-08-05
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
FDA root cause: Under Investigation by firm
Action: Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually, when the table is not tilted. Additionally, consignees were instructed to provide a copy of the notification letter to any organizations to which affected units have been transferred to, to keep the notification letter with system documentation until the correction is complete and complete and return the provided response form. Philips will inspect all affected systems and replace HDDs that are not according to the specifications, as well as correct configurations where different HDD types are used within a single system. Philips expects to start the implementation of this correction in September 2026.
Quantity in commerce: 257 units
Distribution: US Nationwide distribution.
Product codes and lots: Model Number: 722400. 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2893-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2891-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2892-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2893-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

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)