Agency classClass IIOur severity:High FDA (Devices)·Z-2189-2025·Announced 2025-08-06

Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: imaging may be lost during an interventional x-ray procedure, with no injury reported in the source.

Plain-English summary

Philips Allura R8.2.x Systems, running software version R8.2.x, are being recalled across the Allura Xper FD10, FD10/10, FD20 and FD20/10 models listed in the recall notice, model numbers 722026, 722027, 722028 and others. The action covers 4,508 units.

The stated reason is the potential for temporary loss of imaging (X-ray) functionality due to a software issue. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States and to Algeria, Argentina, Australia and Austria among other markets. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model numbers, UDI numbers and software version above and follow the instructions issued by Philips.

The recalled product

Product: Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table…
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Interventional x-ray system
Hazard: software-issue
imaging-loss
interventional-xray
class-ii
Affected units: 4,508

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

(01)00884838054189(21)156
(01)00884838054189(21)253
(01)00884838054189(21)287
(01)00884838054189(21)825
(01)00884838054189(21)394
(01)00884838054189(21)713
(01)00884838054189(21)465
(01)00884838054189(21)74
(01)00884838054189(21)462
(01)00884838054189(21)192
(01)00884838054189(21)191
(01)00884838054189(21)522
(01)00884838054189(21)204
(01)00884838054189(21)155
(01)00884838054189(21)1132
(01)00884838054189(21)967
(01)00884838054189(21)205
(01)00884838054189(21)1246
(01)00884838054189(21)122
(01)00884838054189(21)259

Distribution

Distributed nationwide across the United States.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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