CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
ORT300, operating room table recalled by IMRIS Imaging
Imris Imaging is recalling ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3034-2026
- FDA event ID
- 99596
- Recalling firm
- Imris Imaging, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Aug 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +20 days |
| 2 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Questions about this recall
Why was it recalled?
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 lots are affected?
114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99596This product is part of a recall event; the main page for the event is ORT200, operating room table recalled by IMRIS Imaging.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ORT200, operating room table recalled by IMRIS Imaging | Imris Imaging | Device Malfunction | Nationwide |
More recalls from Imris Imaging
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ORT200, operating room table recalled by IMRIS Imaging | Imris Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Head Fixation Device HFD100 recalled by IMRIS Imaging | Imris Imaging | Device Malfunction | Nationwide |
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