FDA Device recall Z-1130-2019
Azurion FlexArm, 722079
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Azurion FlexArm, 722079 by Philips North America, citing during manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1130-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-12 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | FL |
Product
Azurion FlexArm, 722079
Reason
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
Identifiers
| code_info | Serial numbers 637, 638 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1130-2019%22
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