Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

Plain-English summary

Philips Allura R8.2.x Systems, running software version R8.2.x, are being recalled across the Allura Xper FD10, FD10/10, FD20 and FD20/10 models listed in the recall notice, model numbers 722026, 722027, 722028 and others. The action covers 4,508 units.

The stated reason is the potential for temporary loss of imaging (X-ray) functionality due to a software issue. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States and to Algeria, Argentina, Australia and Austria among other markets. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model numbers, UDI numbers and software version above and follow the instructions issued by Philips.

The recalled product

Product

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Interventional x-ray system

Hazard

• software-issue
• imaging-loss
• interventional-xray
• class-ii

Affected units

4,508

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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