FDA Device recall Z-2284-2026

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…

• FDA Device
• Class II
• ongoing
• Published 2026-06-10

On 2026-06-10 the FDA classified a Class II recall of Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So… by Philips Medical Systems Nederland B V, citing 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 to….

Read the official FDA Device notice

Product

Philips Azurion 3M12, Model Numbers: 722063, 722221 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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Other recalls by Philips Medical Systems Nederland B V

• Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058
  FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V
• Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and…
  FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V
• Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 72222…
  FDA Device · Class II · 2026-08-19 · Philips Medical Systems Nederland B V
• Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10
  FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V
• Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12
  FDA Device · Class II · 2026-08-12 · Philips Medical Systems Nederland B V

All Philips Medical Systems Nederland B V recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2284-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.