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

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.

Distribution

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