FDA Device recall Z-0717-2018
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Car…
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Car… by Philips Electronics North America, citing extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the tw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0717-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: 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 FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)
Reason
Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.
Identifiers
| code_info | All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001 722002…All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001 722002 722003 722010 722026 722005 722011 722027 722006 722012 722028 722008 722013 722015 722023 722035 722020 722029 722038 722039 722058 722059 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0717-2018%22
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