FDA Device recall Z-2225-2026

Philips Azurion systems not configured with an optional auxiliary pan handle

• FDA Device
• Class II
• ongoing
• Published 2026-05-27

On 2026-05-27 the FDA classified a Class II recall of Philips Azurion systems not configured with an optional auxiliary pan handle by Philips Medical Systems Nederland B V, citing potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the….

Read the official FDA Device notice

Product

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

Reason

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

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-2225-2026%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.