DRAD-3000E — Class II medical device recall Z-2964-2018
Terminated recall by Canon Medical System, USA, INC., reported 2018-09-12, distributed in AR, FL, GA, IL, LA, MI, NC, NJ…. It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message w
| Recall number | Z-2964-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2018-04-18 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2021-05-13 |
| Distributed | AR, FL, GA, IL, LA, MI, NC, NJ, NY, OH, PA, TN, TX, UT, VT, WI, WV |
| Countries outside the US | AU, CA, KR, MY, NL |
| Quantity | 43 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2964-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.