IMRIS ORT300 operating room table recalled for rotational lock mechanism failure risk
What this means
IMRIS Imaging Inc has recalled certain ORT300 operating room tables because the rotational lock mechanism may fail mechanically, preventing the table from locking or unlocking as intended. This could allow unintended movement during surgery, potentially injuring a patient. The recall affects 13 units with specific serial numbers.
- If your facility operates an affected ORT300 table, stop using it immediately and verify your serial number against the FDA recall notice.
- Contact IMRIS Imaging Inc or the FDA for repair or replacement instructions.
- Review the complete recall notice at FDA.gov for your specific part number and serial number.
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-3034-2026More IMRIS recalls
- FDA-Device2026-09-02IMRIS ORT200 operating room table recalled for mechanical lock failure risk
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