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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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