FDA Medical Device Recalls (openFDA)
Invivo Corporation: Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
- Recall number
- Z-2688-2016
- Recalling firm
- Invivo Corporation
- Product
- Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
- Status
- Terminated
- Initiated
- 2016-05-06
- Posted
- not on file
- Terminated
- 2019-08-21
- Reason
- A diode was inadvertently not assembled into the system, which may result in coil overheating
- Root cause
- Under Investigation by firm
- Action
- not on file
- Quantity
- 3
- Distribution
- WI
- Lot, serial or model codes
- Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
- 510(k) numbers
- ["K100113"]
- PMA numbers
- not on file
- Product code
- MOS
- Firm FEI
- 1000113495
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28