Events

Recall of Shimadzu Carm Table

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
    72376
  • Event Risk Class
    Class 2
  • Event Number
    Z-0251-2016
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140820
  • 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
    Medical Imaging Table. - Product Code JAA
  • Reason
    The c-arm may interfere with the table top under certain circumstances.
  • Action
    An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.

Device

Shimadzu Carm Table
  • Model / Serial
    Serial Numbers: 0161H25201 0161H25702 0161H25801 0161H28201 0161H27301  0261H26201  0161H29501  0161H29901  0261H26101  0261H26002 0161H25401 0161H29302 0161H26201 0161H27102 0161H25701 0161H26402 0161H26701 0161H29001 0161H26302 0161H25602 0161H26702 0161H28501 0261H25401 0161H28001  0161H27402  0161H27201
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
  • Product Description
    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
  • 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