IMRIS ORT300 Operating Room Table Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
IMRIS Imaging Inc has initiated a Class II recall of 13 ORT300 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.
Before acting, the primary agency source is available to check alongside this summary. 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
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600. A total of 13 units are affected. Specific serial numbers: 114093-000 (UDI-DI: 00857534006356): 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 (UDI-DI: 00857534006462): 10002996, 10004515, 10007411, 10007376. Distributed worldwide including US Nationwide, Canada, China, Japan, and Sweden. Recall number Z-3034-2026.
What You Should Do
Consumers with affected units should refer to the recall notice for further guidance from the recalling firm.
Why This Matters
The recall affects devices used in operating rooms where mechanical failure could lead to unintended movement during procedures.
Source
FDA recall Z-3034-2026, IMRIS Imaging Inc, Chaska, MN.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Medline Convenience Kits Recall Over ChloraPrep Applicator Sterility Breach (Ref. 2fe0d4)
FDA · September 16, 2026
Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 1adab6)
FDA · September 16, 2026
Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Ref. 929d71)
FDA · September 16, 2026
Similar notices nationwide by length or severity timing 8
Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,157 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 8, 2026.
What People Ask
Questions readers often have about this FDA recall.