Events

Recall of Device Recall Affirm Lateral Arm Upright Biopsy Accessory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78777
  • Event Risk Class
    Class 2
  • Event Number
    Z-0351-2018
  • Event Initiated Date
    2017-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160416
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Biopsy needle guide kit - Product Code OIJ
  • 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.
  • Action
    Letter

Device

Device Recall Affirm Lateral Arm Upright Biopsy Accessory
  • Model / Serial
    UDI Number: 15420045506817 Serial Numbers: LAT1200100 LAT1200165
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and OUS
  • Product Description
    Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Manufacturer Address
    Hologic, Inc., 36 and 37 Apple Ridge Rd, Danbury CT 06810-7301
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA