Philips X-Ray Systems — Class II medical device recall Z-1066-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-03-16, distributed nationwide. Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
| Recall number | Z-1066-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2015-10-01 |
| Classified | 2016-03-07 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2020-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 196 devices |
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 for recall
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1066-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.