Azurion interventional systems recalled over nine identified software issues

Plain-English summary

Philips Azurion Systems R3.0 are being recalled, covering the Azurion 3 M12 (model 722229), Azurion 3 M15 (722230), Azurion 5 M12 (722231) and Azurion 5 M20 among the models listed in the enforcement record.

The record cites nine identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, the system continuing to restart, AMD 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 position error.

The record lists 990 units running software version R3.0, 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.

Loss of live X-ray during an interventional procedure interrupts the imaging the operator is working from. The enforcement record reports no injuries. Facilities should follow Philips' instructions.

The recalled product

Product

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Category

Medical Device — Interventional X-ray

Hazard

• software-fault
• loss-of-imaging
• system-restart

Affected units

990

Is your product affected?

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

Distribution

Related recalls