FDA Device recall Z-3217-2018
INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic…
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic… 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-3217-2018 |
| 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
INTEGRIS Allura 15-12 (biplane), System Code 722044 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3217-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.