Reported Sep 7, 2016 · Terminated
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
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 · 3545 SW 47th Ave · Gainesville, FL · 32608-7691
Is this the product you have?
- Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
- Lot codes and dates
Model #: 9896-032-14382Serial #: 13 (production order 301128446)14 (production order 301153586)and 15 (production order 301153587)
- Amount recalled
- 3
Where it was sold
Why it was recalled
A diode was inadvertently not assembled into the system, which may result in coil overheating
This product could cause temporary or reversible health problems — stop using it.
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