Agency classClass IIOur severity:Severe FDA (Devices)·Z-2891-2026·Announced 2026-08-12

Philips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives

Philips is recalling 5,012 Allura interventional fluoroscopic X-ray systems nationwide due to potential loss of imaging functionality, motorized movement, or data caused by unauthorized hard disk drives.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a medical device with potential loss of imaging functionality and motorized movement, which could impact patient care. Per the rubric, FDA Class II recalls are rated Severe (score 4).

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 5,012 units of its Allura interventional fluoroscopic X-ray systems. The recall covers multiple Allura Xper system models and corresponding model numbers, distributed nationwide in the United States.

The recall is due to the use of unauthorized hard disk drives, which may result in a potential loss of imaging functionality, loss of motorized movement, or loss of data.

Healthcare facilities and users operating the affected Philips Allura X-ray systems are advised to contact Philips Medical Systems for further instructions and corrective action.

The recall was classified by the FDA as a Class II recall, indicating a potential risk of temporary adverse health consequences if the issue is not addressed.

The recalled product

Product: Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4.…
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Interventional Fluoroscopic X-Ray System
Hazard: loss-of-function
data-loss
unauthorized-component
Affected units: 5,012

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)

1. Allura Xper FD10
Model Numbers (UDI Numbers): 722003 (N/A)
722010 ((01)00884838059030(21)754
(01)00884838059030(21)42
(01)00884838059030(21)500
(01)00884838059030(21)68
(01)00884838059030(21)521
(01)00884838059030(21)33
(01)00884838059030(21)1025
(01)00884838059030(21)668
(01)00884838059030(21)585
(01)00884838059030(21)641
(01)00884838059030(21)968
(01)00884838059030(21)890
(01)00884838059030(21)780
(01)00884838059030(21)667
(01)00884838059030(21)1279
(01)00884838059030(21)344
(01)00884838059030(21)359
(01)00884838059030(21)423

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

See all →

High
Philips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue
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Philips Azurion Fluoroscopy System Recall for Software Image Quality Issues
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Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures
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High
Philips Fluoroscopy System Recall Over Hard Disk Drive Issue
FDA (Devices) · 2026-08-12

Same hazard · loss of function