Invivo Expression MRI Patient Monitoring System Recalled for Detached Caster Risk
Invivo Corporation is recalling the Expression MRI Patient Monitoring System because a caster may detach during transport, causing the cart to fall.
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 (falling cart) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Invivo Corporation is recalling the Expression MRI Patient Monitoring System. The system is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures and provides signals for synchronization to the MR scanner.
The recall is being conducted because during transport of the system's cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall.
A total of 543 units are affected. The products were distributed nationwide in the United States and in various countries including Canada, Italy, Thailand, and the United Kingdom. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for…
- Manufacturer
- Invivo Corporation
- Affected units
- 543
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 (20)
- Model number 865214: (Service Numbers 453564180091
- 453564181201). Lot numbers: US00201487
- US00201488
- US00201489
- US00201490
- US00201493
- US11401510
- US11401511
- US11401513
- US11401514
- US11401515
- US11401516
- US11401531
- US11401532
- US11401533
- US11401546
- US11401562
- US11401563
- US11401564
- US11401565
Distribution
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