ORT300 — Class II medical device recall Z-3034-2026
Ongoing recall by IMRIS Imaging Inc, reported 2026-09-02, distributed nationwide. The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents
| Recall number | Z-3034-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMRIS Imaging Inc, Chaska, MN, United States |
| Recall initiated | 2026-08-06 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, JP, SE |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 00857534006356, 00857534006462 |
| Serial numbers | 10002841, 10002996, 10002997, 10002998, 10004372, 10004515, 10005456, 10005612, 10005613, 10005695, 10007376, 10007411, 10011119, 114093-600 |
| Model numbers | 114093-000, 114093-600 |
Product
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3034-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.