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U.S. Department of Health and Human Services

Class 2 Device Recall Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE1 .5/3T

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 Class 2 Device Recall Sentinelle Vanguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE1 .5/3Tsee related information
Date Initiated by FirmMay 06, 2016
Create DateAugust 30, 2016
Recall Status1 Terminated 3 on August 21, 2019
Recall NumberZ-2688-2016
Recall Event ID 74064
510(K)NumberK100113 
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
ProductInvivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Code Information Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
FEI Number 1000113495
Recalling Firm/
Manufacturer		 Invivo Corporation
3545 SW 47th Ave
Gainesville FL 32608-7691
For Additional Information ContactKen Revannaugh
352-336-0010
Manufacturer Reason
for Recall		A diode was inadvertently not assembled into the system, which may result in coil overheating
FDA Determined
Cause 2		Under Investigation by firm
Quantity in Commerce3
DistributionWI
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MOS
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