Allura Xper FD20/15 R8 — Class II medical device recall Z-0925-2017
Terminated recall by Philips Electronics North America Corporation, reported 2017-02-01. Due to a production error, screws were not tightened to specified torque. These screws may come loose from the
| Recall number | Z-0925-2017 |
|---|---|
| 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 | 2016-12-01 |
| Classified | 2017-01-20 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-08-10 |
| Countries outside the US | CN, DE, ES, KR |
| Quantity | 2 |
Product
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Reason for recall
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
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-0925-2017. 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.