Events

Recall of Device Recall AortaScan AMI 9700

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Verathon, 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
    56411
  • Event Risk Class
    Class 2
  • Event Number
    Z-0004-2011
  • Event Initiated Date
    2010-08-23
  • Event Date Posted
    2010-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93548
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    The aortascan ami 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
  • Action
    Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to: " Add the enclosed addendum to their current Users Manual. " Update the application software of the device to v2.7.0 or higher. If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or cservice@verathon.com.

Device

Device Recall AortaScan AMI 9700
  • Model / Serial
    Serial numbers:   A7001001, A7001005, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001048, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001062, A7001065, A7001066, A7001067, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001093, A7001094, A7001095, A7001096, A7001097, A7001098, A7001099, A7001100, A7001101, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001133, A7001134, A7001135, A7001136, A7001138, and A7001139.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
  • Product Description
    AortaScan AMI 9700 || The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Manufacturer Address
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA