FDA Device recall Z-1969-2025
Azurion R1.x and R2.x systems
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Azurion R1.x and R2.x systems by Philips Medical Systems Nederland B V, citing A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1969-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;
Reason
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Identifiers
| code_info | Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 7222…Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; UDI-DIs: (1) 00884838085275, (2) 00884838085282, (3) 00884838085350, (4) 00884838085367, (5) 00884838085251, (6) 00884838085268, (7) 00884838099203, (8) 00884838099210, (9) 00884838099241, (10) 00884838099258, (11) 00884838099265, (12) 00884838099272, (13) 00884838099227, (14) 00884838099234, (15) Not commercialized in the US, (16) Not commercialized in the US, (17) Not commercialized in the US; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1969-2025%22
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