Hologic ATEC ILS Brown Cap In Operating instructions

Brand
Hologic
Model
ATEC ILS Brown Cap In
Type
Operating instructions

Hologic ATEC ILS Brown Cap In is a medical device used for MRI biopsy procedures. It is designed to provide a secure connection between the introducer sheath and the brown cap, preventing detachment and potential needle stick injuries. The device is easy to use, requiring only a simple rotational force to apply the brown cap to the introducer sheath. Prior to each use, it is recommended to visually inspect the device to ensure the brown cap is securely attached. If the cap is found to be loose, the device should be exchanged and Hologic should be notified.

Hologic ATEC ILS Brown Cap In is a medical device used for MRI biopsy procedures. It is designed to provide a secure connection between the introducer sheath and the brown cap, preventing detachment and potential needle stick injuries. The device is easy to use, requiring only a simple rotational force to apply the brown cap to the introducer sheath. Prior to each use, it is recommended to visually inspect the device to ensure the brown cap is securely attached. If the cap is found to be loose, the device should be exchanged and Hologic should be notified.

ATEC Customer Letter
Urgent Medical Device Correction
MAN-08718, 001, May 2021 Hologic Page 1 of 1
250 Campus Drive, Marlborough, MA 01752 (800) 447-1856 Published May 10, 2021
© 2021 Hologic, Inc. The information contained in this document is proprietary. Unauthorized distribution is prohibited.
Dear Valued Hologic Customer:
This is to inform you of a voluntary product field action involving:
Product(s):
• ILS 0914-12: 9G Introducer Localization Set for ATEC 0914-12MR Handpiece
• ILS 0914-20: 9G Introducer Localization Set for ATEC 0914-20MR Handpiece
Serial Lot Numbers:
• Product with lot numbers 20Jddnn or later (where 20 is year 2020, J is month of September, dd is date
of manufacture, nn is sequential number)
This field action was initiated to address customer complaints on the ATEC ILS kits regarding detachment of
the brown cap from the introducer sheath. We are notifying you because you have purchased the affected
products with lot numbers identified within the scope of the correction. The product issue has the potential to
result in a needle stick.
Figure 1.0 ILS Assembly Intact Figure 2.0 Brown Cap Detached
Based on Hologic investigation, the following instructions for use are recommended for impacted lots of
product.
Prior to use of the ILS:
1. Visually inspect to confirm the brown cap is adhered to the white introducer sheath.
2. Apply rotational force to the brown cap while holding the white introducer sheath steady.
3. If the cap is loose, exchange this device with another kit and notify Hologic of the issue by contacting
breasthealth.support@hologic.com.
To prevent interruption to MRI biopsy procedures, Hologic will continue to supply ILS kits while the
investigation and corrective action for this issue are underway.
At Hologic, we are committed to continually evaluating and improving the quality and reliability of our
products. We value your business and thank you for your cooperation during this time. Our goal is to ensure
the continued safe use of your system in a manner that creates as little disruption to your practice as possible.
If you have any questions, please do not hesitate to reach out to Technical Support at
breasthealth.support@hologic.com or 1-877-371-4372.
Sincerely,
Robert Kielinen
Sr. Director, Quality
Hologic, Inc.
Brown Cap
Introducer
Sheath
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Hologic ATEC ILS Brown Cap In Operating instructions

Brand
Hologic
Model
ATEC ILS Brown Cap In
Type
Operating instructions

Hologic ATEC ILS Brown Cap In is a medical device used for MRI biopsy procedures. It is designed to provide a secure connection between the introducer sheath and the brown cap, preventing detachment and potential needle stick injuries. The device is easy to use, requiring only a simple rotational force to apply the brown cap to the introducer sheath. Prior to each use, it is recommended to visually inspect the device to ensure the brown cap is securely attached. If the cap is found to be loose, the device should be exchanged and Hologic should be notified.

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