FDA Device recall Z-3034-2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 by Imris Imaging, citing the linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. Thi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3034-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-06 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Imris Imaging |
| Distribution | US |
Product
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Reason
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
Identifiers
| code_info | 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 100056…114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3034-2026%22
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