IMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
IMRIS Imaging Inc is recalling six ORT200 operating room tables because a mechanical failure could cause unintended movement and patient injury.
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 is classified as FDA Class II and involves a risk of patient injury from unintended movement, but no injuries or illnesses have been reported.
Plain-English summary
IMRIS Imaging Inc is recalling six units of the 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). The recall involves specific serial numbers: 10003754 and 10006997 for Part Number 113821-600, and 10005189, 10005190, 10004463, and 10004997 for Part Number 114148-000.
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, posing a risk of injury to the patient if unintended rotational movement occurs during a procedure.
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
- 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
- Manufacturer
- IMRIS Imaging Inc
- Affected units
- 6
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 (7)
- 113821-600 - Serial Numbers: 10003754
- 10006997
- 114148-000 - UDI-DI: 00857534006349
- Serial Numbers: 10005189
- 10005190
- 10004463
- 10004997
Distribution
Distributed nationwide across the United States.
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