Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper… — Class II medical device recall Z-0346-2016
Terminated recall by Philips Medical Systems, Inc., reported 2015-12-09, distributed nationwide. Monitor Ceiling Suspension system may fall
| Recall number | Z-0346-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2015-02-03 |
| Classified | 2015-11-30 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2017-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CL, CN, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, ZA |
| Quantity | 9 units |
| Model numbers | 722003 |
Product
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Reason for recall
Monitor Ceiling Suspension system may fall
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-0346-2016. 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.