Events

Recall of Device Recall Axiom Sensis Report Workstation

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
    29464
  • Event Risk Class
    Class 2
  • Event Number
    Z-1446-04
  • Event Initiated Date
    2004-05-17
  • Event Date Posted
    2004-09-14
  • 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=33793
  • 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
    Computer, Diagnostic, Programmable - Product Code DQK
  • Reason
    Software issue. allows for users to enter date in pre-cath holding area prior to registering the patient in the cath lab.
  • Action
    The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed to correct the problem.

Device

Device Recall Axiom Sensis Report Workstation
  • Model / Serial
    Serial Numbers 1002, 1034, 1100-1253, 1300-1504
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to 43 medical facilities nationwide and one government account in KY.
  • Product Description
    AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
  • 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