Device product
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Z-2688-2016
Product summary
- Event
- Event 74064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-2688-2016
Official wording
Reason: A diode was inadvertently not assembled into the system, which may result in coil overheating
Code information: Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
Distribution pattern: WI
Derived failure modes
-
Unknown
A diode was inadvertently not assembled into the system, which may result in coil overheating