IMRIS ORT200 Operating Room Table Recall
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IMRIS Imaging Inc is recalling six ORT200 operating room tables due to potential mechanical failure in the linear actuator and rotational lock mechanism.
The full picture behind this FDA recall
This notice was issued by FDA on September 8, 2026 and geographically references Worldwide. The FDA classifies this as a Class II recall, with the stated 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.", distributed worldwide distribution - us nationwide and the countries of canada, china, japan, sweden.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Devices.
What Happened
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.
Which Products Are Affected
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. Affected serial numbers: 113821-600 (10003754, 10006997); 114148-000 (UDI-DI 00857534006349; 10005189, 10005190, 10004463, 10004997). Six units distributed worldwide, including US Nationwide and the countries of Canada, China, Japan, Sweden. Recall number Z-3033-2026, Class II, initiated August 6, 2026.
What You Should Do
No specific consumer actions are detailed in the recall notice.
Why This Matters
The recall involves operating room tables that may experience unintended movement, posing a risk of patient injury during procedures.
Source
FDA recall Z-3033-2026 (report date September 2, 2026).
Original source: FDA Official Notice ↗
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Similar notices nationwide by length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,127 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 8, 2026.
What People Ask
Common questions about this FDA recall.