Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
This recall has been terminated (originally issued May 6, 2016).
- Company
- Invivo Corporation
- Recall Initiated
- May 6, 2016
- Terminated
- August 21, 2019
- Recall Number
- Z-2688-2016
- Quantity
- 3
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
A diode was inadvertently not assembled into the system, which may result in coil overheating
Distribution
WI
Lot / Code Info
Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
Root Cause
Under Investigation by firm