FDA Device recall Z-1120-2015
Philips Medical System Allura Xper X-Ray Angiographic
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Philips Medical System Allura Xper X-Ray Angiographic by Philips Medical Systems, citing in certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1120-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-06 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips Medical System Allura Xper X-Ray Angiographic
Reason
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.
Identifiers
| code_info | Software releases: PBL 10, 20, 30, 40, 50, and 60; CV20; R7.2x; R7.6; R8.1; and R8.2. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1120-2015%22
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