FDA Device recall Z-2688-2016
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems by Invivo, citing A diode was inadvertently not assembled into the system, which may result in coil overheating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2688-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-06 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | WI |
Product
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Reason
A diode was inadvertently not assembled into the system, which may result in coil overheating
Identifiers
| code_info | Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2688-2016%22
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