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Hologic, Inc. recalls Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

Recalled January 24, 2018 · FDA recall Z-0351-2018 · Hologic

Hazard
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. · FDA Class II
Units
12 (U.S.)
Sold at
US and OUS

Description

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.

Product
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Manufacturer(s)
Hologic, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Hologic, Inc. recalls Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 | RecallWatchUSA