Agency classClass IIOur severity:High FDA (Devices)·Z-0676-2025·Announced 2024-12-18

Philips Allura Xper X-ray Systems Prone to Clamping Bolt Failure and Collision Risk

Philips Allura Xper radiological systems may experience propeller motor and x-ray tube locking bolt breaks, causing erratic C-arm movements with potential for collision with patients or bystanders, and unnecessary radiation exposure.

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: This is an FDA Class II recall of a critical medical imaging device with identified risk of patient harm through erratic C-arm movement and potential collision. No injuries or hospitalizations have been reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips has recalled certain Allura Xper Systems (R7.6-R8.1), which are fluoroscopy and imaging systems used in medical facilities. The recall affects approximately 2,782 units with distribution in the United States and internationally.

The recall involves propeller motor clamping bolt and x-ray tube locking bolt breaks in systems over 10 years of age without timely installation of the Lifetime Extension (LTE) kit. The root cause is under investigation.

These mechanical failures may cause the C-arm to move erratically, creating a potential risk of collision with patients or bystanders. The system may also falsely detect collisions, which could block C-arm movement. Image quality degradation with noise and black areas may also occur, potentially requiring patients to undergo additional radiation exposure during re-examination.

The recalled product

Product: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura…
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Radiological Imaging / Fluoroscopy Systems
Hazard: mechanical-failure
erratic-movement
collision-risk
radiation-exposure
Affected units: 2,782

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. Model Number: 722010. UDI (Serial Numbers): (01)00884838054189(21)164 (164)
(01)00884838059030(21)272 (272)
(01)00884838059030(21)819 (819)
(01)00884838059030(21)828 (828)
No UDI (33
39
42
43
65
67
69
79
107
119
127
158
160
169
177
190

Distribution

Distributed nationwide across the United States.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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