Reported Dec 12, 2012 · Terminated
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended…
Invivo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invivo Corporation · 12151 Research Pkwy · Orlando, FL · 32826-3222
Is this the product you have?
- 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 synchronization to the MR scanner.
- Lot codes and dates
- Model number 865214
(Service Numbers 453564180091453564181201)
- Lot numbers
543 of 543 codes
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- Model number 865214
- Amount recalled
- 543 units
Where it was sold
Why it was recalled
Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems 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.
This product could cause temporary or reversible health problems — stop using it.
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