IMRIS ORT200 operating room table recalled for mechanical lock failure risk
What this means
A mechanical failure in the linear actuator and rotational lock mechanism on certain IMRIS ORT200 operating room tables may prevent the table from locking or unlocking properly. If the table becomes unlocked unintentionally during surgery, it could move unexpectedly and injure the patient.
- If your facility operates an affected ORT200 table (Part Numbers 113821-600 or 114148-000 with the listed serial numbers), stop using it immediately.
- Contact IMRIS Imaging Inc for instructions on inspection, repair, or replacement.
- Check the serial number on your table against the list in the FDA notice to confirm if your unit is affected.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3033-2026More IMRIS recalls
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