FDA Device recall Z-1066-2016
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiova…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiova… by Philips Electronics North America, citing upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1066-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-01 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.
Reason
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Identifiers
| code_info | Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1066-2016%22
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