Recall Z-0351-2018— Hologic, Inc.
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc., initiated 2017-07-07, terminated 2018-04-04. It names one FDA 510(k) clearance: K161575. Product: Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880. Reason: The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury..
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-07
- Terminated
- 2018-04-04
- Firm location
- Danbury, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Reason for recall
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.