FDA Device recall Z-0348-2016
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and va…
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and va… by Philips Medical Systems, citing monitor Ceiling Suspension system may fall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0348-2016 |
| 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 INTEGRIS cardio system Model : 722121 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 | S/N: 1656 1667 1687 1668 1669 1670 1671 1685 |
|---|
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-0348-2016%22
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