Agency classClass IIOur severity:High FDA (Devices)·Z-2928-2026·Announced 2026-08-19

Philips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue

Philips is recalling 4,252 Allura Xper FD interventional fluoroscopic x-ray systems worldwide due to a firmware issue that may cause loss of geometry movements.

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: The recall is classified as FDA Class II and involves a functional defect in a medical device that could impact patient safety, but the source text does not report any injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling 4,252 units of the Allura Xper FD interventional fluoroscopic x-ray system. The affected model numbers are 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058, running software version R8.2. The recall covers units distributed in the United States and numerous countries worldwide, including Canada, Australia, Germany, Japan, and the United Kingdom.

The recall is being conducted due to a firmware issue that potentially leads to a loss of geometry movements. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The FDA has classified this recall as Class II, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users of these systems should contact Philips Medical Systems Nederland B.V. for instructions on how to resolve the firmware issue. The recall number is Z-2928-2026.

The recalled product

Product: Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category: Medical Device — Imaging Equipment
Hazard: firmware-defect
loss-of-geometry
Affected units: 4,252

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)

Model Numbers: 722026
722027
722028
722029
722035
722038
722039
722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756
(01)00884838054202(21)1569
(01)00884838059115(21)100
(01)00884838059115(21)239
(01)00884838054202(21)520
(01)00884838054202(21)1956
(01)00884838054189(21)683
(01)00884838054196(21)351
(01)00884838054202(21)129
(01)00884838059115(21)305
(01)00884838054196(21)332
(01)00884838054202(21)1233
(01)00884838054202(21)2206

Distribution

Distributed nationwide across the United States.

Same manufacturer · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Same hazard · firmware defect