Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with… — Class II medical device recall Z-2688-2016
Terminated recall by Invivo Corporation, reported 2016-09-07, distributed in WI. A diode was inadvertently not assembled into the system, which may result in coil overheating
| Recall number | Z-2688-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Gainesville, FL, United States |
| Recall initiated | 2016-05-06 |
| Classified | 2016-08-30 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2019-08-21 |
| Distributed | WI |
| Quantity | 3 |
| Reason classes | device malfunction |
| Model numbers | 9896-032-14382 |
Product
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Reason for recall
A diode was inadvertently not assembled into the system, which may result in coil overheating
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2688-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.