Recall Z-2964-2018— Canon Medical System, USA, INC.
Class II · Terminated
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2018-04-18, terminated 2021-05-13. It names one FDA 510(k) clearance: K122842. Product: DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD). 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
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-18
- Terminated
- 2021-05-13
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.