Events

Recall of Device Recall ACOM.M angiographic x ray system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
    29823
  • Event Risk Class
    Class 2
  • Event Number
    Z-1477-04
  • Event Initiated Date
    2004-06-16
  • Event Date Posted
    2004-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34594
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Possible problem reviewing images on the acom.M.
  • Action
    Strategy: The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions AX026/04/S. The letter informs the customers of the potential problem and provides preventive measures to avoid this occurrence.

Device

Device Recall ACOM.M angiographic x ray system
  • Model / Serial
    Serial numbers: 1024 through 1639
  • Product Classification
    Radiology Devices
  • Distribution
    Shipping: The product is shipped to 100 medical facilities in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and 2 government accounts in CA and WI.
  • Product Description
    ACOM.M angiographic x ray system. Model number 4371741
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA