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Devices
Device Recall VIGILANCE MONITOR
Model / Serial
Lot Numbers: All devices serialized with software release 5.3 or earlier.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide
Product Description
EDWARDS VIGILANCE MONITORS || (FORMERLY BAXTER VIGILANCE MONITORS) || with software release 5.3 or earlier only. Patient monitor which measures cardiac output. || Models: VG, VGS, VGS1, VGS2, VG2, & IVM.
Manufacturer
Edwards Lifesciences Llc
1 Event
Recall of Device Recall VIGILANCE MONITOR
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Manufacturer
Edwards Lifesciences Llc
Manufacturer Address
Edwards Lifesciences Llc, One Edwards Way, Irvine CA 92614-5688
Source
USFDA
Language
English
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