31

Aug

2018

Recall – Canon DRAD-3000E (Radrex-i) TFP-4336W Cl II

0

Company:Canon Medical System, USA, INC.
Date of Enforcement Report 9/12/2018
Class lI:

PRODUCT

Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
Recall Number: Z-2964-2018

REASON
It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there was no image. It also showed the OK button to reacquire image data form the FPD, and the Cancel button to cancel the reacquisition. When the operator selects the OK button, the same message window appears. The operator then repeated the same operation several times and finally selected the Cancel button to quit the reacquisition mode.

RECALLING FIRM/MANUFACTURER
Canon Medical System, USA, INC. Tustin, CA on 4/18/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
43

DISTRIBUTION
Domestic: AR, FL, GA, PA, IL, LA, MI, NC, NJ, NY, OH, TN, TX, UT, VT, WI, and WV Foreign: Australia, Canada, The Netherlands, South Korea, and Malaysia

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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