FDA Device recall Z-2892-2026

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12

• FDA Device
• Class II
• ongoing
• Published 2026-08-12

On 2026-08-12 the FDA classified a Class II recall of Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12 by Philips Medical Systems Nederland B V, citing potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Read the official FDA Device notice

Product

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.

Reason

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

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 Allura, Cardio Vascular-Allura Centron
  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-2892-2026%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.