FDA recall Z-2286-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · device

Product

Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2023-12-07
Report date: 2026-06-10
Voluntary/Mandated
Location: Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2286-2026