Azurion systems recalled over six identified software issues

Plain-English summary

Philips Azurion Systems with software versions R2.1.10 and R2.2.10 are being recalled, covering the Azurion 3 M12 (models 722063 and 722221) and Azurion 3 M15 (models 722064, 722222 and 722280) among the models listed in the enforcement record.

The record cites six identified software issues which may result in the following: the system keeps restarting, AMC triple drive, the C-Partition of the Suite PC running out of free space, the system remaining in continuous restart mode after start-up, misalignment of the Marker Tool Overlay, and a longitudinal positional error.

The record lists 10,466 units, with model numbers and UDI pairings recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States and to a wide range of other countries. The FDA has classified the action as Class II.

The record describes system restart and display faults and states no further consequence or reported injuries. Facilities should follow Philips' instructions.

The recalled product

Product

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Interventional X-ray

Hazard

• software-fault
• system-restart
• overlay-misalignment

Affected units

10,466

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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