Philips Azurion X-Ray Systems Table Movement Control Defect Recall

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling certain Azurion X-ray imaging systems that were not configured with an optional auxiliary pan handle. The systems affected include multiple models: Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, and Azurion 7 M20, with a total of 5,537 units recalled.

A potential safety issue has been identified where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. This wear could result in reduced or compromised table positioning capabilities during clinical use.

The recalled systems were distributed nationwide in the United States and to multiple countries including Canada, Australia, Japan, and others. Healthcare facilities and providers with affected Azurion systems should contact Philips Medical Systems Nederland B.V. for guidance on inspection, repair, or replacement options to ensure proper device functionality.

The recalled product

Product

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3.

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Diagnostic Imaging / X-ray System

Hazard

• mechanical-wear
• table-movement-impairment
• device-malfunction

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.