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

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. Allura

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.

Distribution

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