FDA Device recall Z-3231-2018
AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications… by Philips Electronics North America, citing there is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3231-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-16 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
Reason
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Identifiers
| code_info | All systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America
All Philips Electronics North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3231-2018%22
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