IMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
IMRIS Imaging Inc is recalling 13 ORT300 operating room tables because a mechanical failure could cause unintended rotational movement, posing a risk of injury to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
IMRIS Imaging Inc is recalling 13 units of the ORT300 operating room table, specifically the Modular Table Main Unit Assembly with part numbers 114093-000 and 114093-600. The recall involves specific serial numbers listed in the agency documentation.
The recall is due to a potential mechanical failure in the linear actuator and rotational lock mechanism components. This failure may prevent the system from transitioning between locked and unlocked states, which could result in unintended rotational movement during a procedure and pose a risk of injury to the patient.
The affected units were distributed worldwide, including the United States, Canada, China, Japan, and Sweden. Healthcare facilities should contact IMRIS Imaging Inc for instructions on how to address the defect.
The recalled product
- Product
- ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
- Manufacturer
- IMRIS Imaging Inc
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · IMRIS Imaging Inc
See all →- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighHead fixation devices recalled because a torque screw may crack or separate
FDA (Devices) · 2026-01-14
Same hazard · mechanical failure
See all →- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- SevereJayco Recalls 2027 Fifth Wheel Trailers Due to Auto Leveling Jack Defect
NHTSA · 2026-08-06