Events

Recall of Device Recall Axiom Sensis

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
    25930
  • Event Risk Class
    Class 2
  • Event Number
    Z-0979-03
  • Event Initiated Date
    2003-02-28
  • Event Date Posted
    2003-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26731
  • 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 problem - erroneous results or system crashes.
  • Action
    The recalling firm issued a Customer Safety Advisory Letter to their customers. The letter instructed the customer to insert the letter into their operator''s manual and that updated software would be released in May 2003.

Device

Device Recall Axiom Sensis
  • Model / Serial
    Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped two medical facilities in MA and MI and two units were used as demonstration units by the recalling firm.
  • Product Description
    Axiom Sensis. Programmable Diagnostic Computer
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Parkway, Malvern PA 19355
  • Source
    USFDA