Device product
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Z-0351-2018
Product summary
- Firm
- Hologic, Inc.
- Event
- Event 78777
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 (U.S.)
- Official record key
device-enforcement:Z-0351-2018
Official wording
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.
Code information: UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Distribution pattern: US and OUS
Derived failure modes
-
Unknown
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.