Events

Recall of Device Recall MicroScan WalkAway40 plus Instrument and MicroScan Walkaway96 plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    68524
  • Event Risk Class
    Class 2
  • Event Number
    Z-1990-2014
  • Event Initiated Date
    2014-06-02
  • Event Date Posted
    2014-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128140
  • 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
    Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
  • Reason
    Springs contained in the access door hinge assembly on the walk away plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
  • Action
    Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.

Device

Device Recall MicroScan WalkAway40 plus Instrument and MicroScan Walkaway96 plus
  • Model / Serial
    WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.
  • Product Description
    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. || Siemens Healthcare Diagnostics, Inc. || in vitro diagnostic
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA