FDA Device recall Z-0226-2024
Zenition 50 & 70 Mobile Surgery C-arm
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Zenition 50 & 70 Mobile Surgery C-arm by Philips North America, citing philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Sour….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0226-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | PR |
Product
Zenition 50 & 70 Mobile Surgery C-arm
Reason
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Identifiers
| code_info | Zenition 50 974 Zenition 50 1244 Zenition 50 1247 Zenition 50 892 Zenition 70 1735 Zenition 70 1824 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0226-2024%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.