Z-2688-2016Class II

Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T...

Name: Z-2688-2016 Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T...
Creator: Invivo Corporation
Published: 2016-05-06
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2016-05-06 / Terminated

FDA source

Invivo Corporation began a recall of Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems on 2016-05-06. FDA classified it as Class II and gives the reason as "A diode was inadvertently not assembled into the system, which may result in coil overheating". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2688-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-06
Posted: 2016-08-30
Terminated: 2019-08-21
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.
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: A diode was inadvertently not assembled into the system, which may result in coil overheating
FDA root cause: Under Investigation by firm
Quantity in commerce: 3
Distribution: WI
Product codes and lots: Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2688-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2688-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-30

Product code MOS

K100113Class IIVanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for Ge 3T MRI System, Model 4000451-51Sentinelle Medical, Inc. / cleared 2010-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)