High FDA (Devices)·Z-0468-2013·Announced 2012-12-12

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.

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 (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 sync
Manufacturer: Invivo Corporation
Category: Medical Device — Patient Monitoring
Hazard: falling-object
structural-defect
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

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Same manufacturer · Invivo Corporation

See all →

Low
Invivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label
FDA (Devices) · 2020-10-28
High
Invivo Recalls MRI Monitor Adapters Due to Insufficient Shielding
FDA (Devices) · 2020-03-11
High
Invivo Xper Flex Cardio Physiomonitoring System Software Recall
FDA (Devices) · 2018-11-21
High
Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error
FDA (Devices) · 2018-09-26
Moderate
Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect
FDA (Devices) · 2018-06-13

Same hazard · falling object