PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.

Recall number

Z-2893-2026

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

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

Status

Open, Classified

Initiated

2026-06-17

Posted

2026-08-05

Terminated

not on file

Reason

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

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

257 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

Model Number: 722400. 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510(k) numbers

["K102005","K130638","K130842","K133292","K141979","K161563"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3042175844

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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