Events

Recall of R20J, Diagnostic Xray Beam Limiting Device

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-0261-2013
  • 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=110037
  • 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
    Collimator, manual, radiographic - Product Code IZX
  • 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

R20J, Diagnostic Xray Beam Limiting Device
  • Model / Serial
    Device Model #R-20J
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    R-20J , Diagnostic X-Ray Beam-Limiting Device. || In combination with any of below X-Ray tubes: || 06/1.2P364DK-85, 0.6/1.2P324DK-125, || 06/1.2P324DK-85, 0.6/1.2P38DE-85. || Product Usage: || The device is the beam-limiting device for X-ray Radiography.
  • 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