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IMRIS ORT200 Operating Room Table
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MEDICAL DEVICE RECALLMODERATE

IMRIS ORT200 Operating Room Table

IMRIS recalls ORT200 operating room tables due to actuator/lock failure risk of unintended movement.

What to do

Stop using the affected ORT200 operating room table immediately and contact IMRIS Imaging Inc for instructions on inspection and repair. Do not use the table until the issue is resolved.

Recalled
Listed
Updated
Recall No.
Z-3033-2026
Agency
FDA
Firm
IMRIS Imaging Inc
Recall ID
99596
Status
ONGOING

Why it was recalled

IMRIS Imaging Inc is recalling the ORT200 operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000. The linear actuator and rotational lock mechanism may fail, preventing the system from transitioning between locked and unlocked states, which could allow unintended rotational movement and pose a risk of injury to the patient during a procedure.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000Z-3033-202610003754, 10006997, 00857534006349, 10005189, 10005190, 10004463, 10004997
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600Z-3034-202600857534006356, 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119, 00857534006462, 10002996, 10004515, 10007411, 10007376

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification