Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Reported: September 7, 2016 Initiated: May 6, 2016 #Z-2688-2016
Product Description
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
Reason for Recall
A diode was inadvertently not assembled into the system, which may result in coil overheating
Details
- Recalling Firm
- Invivo Corporation
- Units Affected
- 3
- Distribution
- WI
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.. Recalled by Invivo Corporation. Units affected: 3.
Why was this product recalled? ▼
A diode was inadvertently not assembled into the system, which may result in coil overheating
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2688-2016.
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