CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report

Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop recalled

Invivo is recalling Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for, distributed in Wisconsin. The recall was initiated on 6 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2688-2016
FDA event ID: 74064
Recalling firm: Invivo, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 6 May 2016
FDA classified: 30 Aug 2016
Reported: 7 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

6 May 2016	Recall initiated by company
30 Aug 2016	Classified by FDA	+116 days
7 Sep 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A diode was inadvertently not assembled into the system, which may result in coil overheating

Product as listed by the FDA

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

Where it was distributed

Wisconsin

Questions about this recall

Why was it recalled?

A diode was inadvertently not assembled into the system, which may result in coil overheating

Which lots are affected?

Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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