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Devices
Device Recall iLab
Model / Serial
Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed to 13 US consignees and 10 foreign consignees.
Product Description
iLab Utrasound Imaging System, software controlled Imaging Catheter.
Manufacturer
Boston Scientific Target
1 Event
Recall of Device Recall iLab
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Manufacturer
Boston Scientific Target
Manufacturer Address
Boston Scientific Target, 4701 Lakeview Blvd, Fremont CA 94537
Source
USFDA
Language
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