FDA Device recall Z-0346-2016
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper…
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper… by Philips Medical Systems, citing monitor Ceiling Suspension system may fall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0346-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-03 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
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
Monitor Ceiling Suspension system may fall
Identifiers
| code_info | System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xp…System : S/N : Model: 722003 30 Allura Xper FD10 722010 670 Allura Xper FD10 722011 167 Allura Xper FD10/10 722012 1951 Allura Xper FD20 722012 536 Allura Xper FD21 722012 504 Allura Xper FD22 722012 748 Allura Xper FD23 722012 536 Allura Xper FD24 722012 579 Allura Xper FD25 |
|---|
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-0346-2016%22
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