Recall Z-2688-2016
Invivo Corporation · initiated May 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Codes / lots: Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
Reason for recall
A diode was inadvertently not assembled into the system, which may result in coil overheating
FDA-determined cause: Under Investigation by firm
Action taken
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Details
- Recall number
- Z-2688-2016
- Initiated
- May 6, 2016
- Terminated
- August 21, 2019
- Product code
- MOS – Coil, Magnetic Resonance, Specialty
- Quantity
- 3
- Distribution
- WI
- Recalling firm
- Invivo Corporation, Gainesville, FL