Recall Z-2964-2018 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Canon Medical System, USA, INC.
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
| Date | Apr 18, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | On 04/18/2018, the firm mailed Urgent: Medical Device Correction letters via USPS return receipt mail. The letter contains a return reply form that is to be faxed. After one month contact will be made with each non-responding location and a copy of the letter will be faxed to that location and the fax receipt will serve as proof of notification. Upon release of the modified software it will be assigned to a firm employee with instructions for implementation at each site. Each incident is assigned unique service incident (case) and the completion of the service incidents are tracked through |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E Toshiba America Medical Systems, In.C, Oct 9, 2012 |