Events

Recall of MobileArt Evolution, MobileDaRt Evolution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Shimadzu Medical Systems.

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
    62271
  • Event Risk Class
    Class 2
  • Event Number
    Z-0263-2013
  • Event Initiated Date
    2011-10-28
  • Event Date Posted
    2012-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110039
  • 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
    System, x-ray, mobile - Product Code IZL
  • Reason
    Shimadzu is recalling diagnostic x-ray beam-limiting device, mobile x-ray system and diagnostic x-ray tube assembly because they do not comply with the product performance standards, 21cfr 1020.30 (m) beam quality --(1) half-value layer (hvl), which was revised in 2006. certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
  • Action
    Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.

Device

MobileArt Evolution, MobileDaRt Evolution
  • Model / Serial
    S/N of X-ray tube: 64510 66036 66026 66027 71866 70641 72470 72740 72735 73360 73365 2XY0084531 73372 73679 73671 73966 74248 74258 74546 74548 74291 74556 74832 74834 74833 74829 74837 76058 76326 76069 76355 76364 76361 76356 76358 76363 76367 2XY0080666 80666 2XY0080650 2XY0080345 2XY0080649 2XY0080656 2XY0082453 2XY0082456 2XY0082461 2XY0082748 2XY0083039 2XY0075448 2XY0082750 2XY0083070 2XY0082778 2XY0083047 2XY0083058 2XY0083680 2XY0083627 2XY0083633 2XY0083951 2XY0084556
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    0.7/1.3U163CS-36 || In combination with below systems || MobileArt Evolution, MobileDaRt Evolution || Product Usage: || The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • Manufacturer Address
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • Manufacturer Parent Company (2017)
    Shimadzu Corp.
  • Source
    USFDA