FDA-Device2016-09-14Class II
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Hologic, Inc
Hazard
Tip Breakage at the glue joint between the obturator body and tip
Sold states
US Nationwide Distribution
Affected count
1440 units
Manufactured in
250 Campus Dr, Marlborough, MA, United States
Products
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2765-2016Don't want to check this manually?
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