FDA Device recall Z-0182-2015
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035 by Philips Medical Systems, citing faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-08 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | IL, TN |
Product
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Reason
Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Identifiers
| code_info | Allura Xper Software version R8.2.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2015%22
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