FDA recall Z-2964-2018

Canon Medical System, USA, INC. · Class II · device

Product

DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)

Reason for recall

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.

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

Key facts

Status
Terminated
Initiation date
2018-04-18
Report date
2018-09-12
Termination date
2021-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2964-2018