Agency classClass IIOur severity:High FDA (Devices)·Z-2766-2016·Announced 2016-09-14

Hologic Recalls SureSight Obturator Introducer Localization Systems Due to Tip Breakage

Hologic is recalling 535 units of SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (tip breakage) in a medical device used during MRI procedures, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Hologic, Inc. is recalling 535 units of the SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. The affected product is the ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece). This sterile accessory kit is sold as an independent product for use with ATEC MRI handpieces and is available in two lengths.

The recall is being conducted because of tip breakage at the glue joint between the obturator body and the tip. The affected units were distributed nationwide in the United States. Specific lot codes for the recalled units include 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, and 605547.

Healthcare facilities and users should stop using the affected SureSight Obturator Introducer Localization Systems and contact Hologic, Inc. for instructions on how to return the product.

The recalled product

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…
Manufacturer: Hologic, Inc
Category: Medical Device — MRI Accessories
Hazard: structural-defect
tip-breakage
Affected units: 535

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot Codes: 512501
512502
512504
512588
601501
601535
601536
601587
602501
602502
602503
602504
603522
604557
604558
604591
605501
605502
605543
605547.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hologic, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hologic, Inc

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