Device product
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator
Z-2766-2016
Product summary
- Firm
- Hologic, Inc
- Event
- Event 74839
- Status
- Terminated
- Classification
- Class II
- Quantity
- 535 units
- Official record key
device-enforcement:Z-2766-2016
Official wording
Reason: Tip Breakage at the glue joint between the obturator body and tip
Code information: Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Tip Breakage at the glue joint between the obturator body and tip