Events

Recall of Device Recall Siemens Axiom Sensis XP

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
    61517
  • Event Risk Class
    Class 2
  • Event Number
    Z-1506-2012
  • Event Initiated Date
    2012-02-22
  • Event Date Posted
    2012-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108334
  • 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
    There is a potential malfunction in the connection of a sensis ep system with carto(r) 3 dedicated cable set (part number 14411343) with the carto 3 system from bionsense webster.
  • Action
    Siemens sent a recall/correction letter dated February 22, 2012, via Update Instruction AX049/11/S of this product to all affected customers. The letter informed customers of the potential issues and provides additional information on the implemented resolution. An Update Instuction AX048/11/S will be available immediately. The update instruction provides a new version of the Carto 3 addendum to the Operator Manual and the exchange of the previous stim cables with the latest cable. For questions call 610-219-4834.

Device

Device Recall Siemens Axiom Sensis XP
  • Model / Serial
    Model number 10608285 - serial numbers 41021, 10006, and 6045.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, NC, and SC.
  • Product Description
    Siemens Axiom Sensis XP diagnostic programmable computer || Diagnostic programmable computer
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA