Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Check against the official notice below — it lists the full affected range.
Hologic, Inc. is implementing a product correction for its Affirm Lateral Arm Upright Biopsy Accessory (model ASY-09880) due to a component issue with either the Left-hand Guide or the Blue Needle Guide. This component problem could affect needle alignment during left-approach lateral biopsy procedures, potentially impacting the position of the needle within the breast and the collection of intended tissue samples. The impact is case-dependent and can be detected through imaging used to confirm needle position and tissue acquisition during and after a procedure. There are no known instances of illness or injury associated with this issue.
Twelve units of this accessory were distributed in the United States, with additional units distributed outside the U.S. The affected units can be identified by UDI Number 15420045506817 and serial numbers LAT1200100 or LAT1200165. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US and OUS Quantity: 12 (U.S.) Lot/code info: UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.