Philips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling Azurion and Allura medical imaging systems due to hard disk drive (HDD) degradation. The recall affects 3,069 units distributed worldwide, including 872 in the United States and 2,224 outside the US.

Hard disk drives used in the systems' computers may show decreased performance as they age, particularly beyond six years of service. Degradation may result in loss of imaging functionality, affecting the system's diagnostic capabilities. In Allura systems specifically, the issue may also lead to loss of motorized movement or data loss. System restarts may temporarily restore functionality in some cases.

Healthcare facilities using affected systems should contact Philips Medical Systems Nederland B.V. for guidance and support. No injuries or illnesses have been reported in relation to this issue.

The recalled product

Product

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Diagnostic Imaging Equipment

Hazard

• hardware-degradation
• loss-of-imaging
• loss-of-function
• data-loss

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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