Devices

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

Model / Serial
Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
WI
Product Description
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Manufacturer
Invivo Corporation
1 Event
- Recall of Device Recall Sentinelle Vanguard Breast MRI , Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE1 .5/3T

Manufacturer

Invivo Corporation

Manufacturer Address
Invivo Corporation, 3545 SW 47th Ave, Gainesville FL 32608-7691
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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