# FDA recall Z-2964-2018

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2018-04-18.

## 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

- **Recall number:** Z-2964-2018
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2964-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2964-2018. Source: US FDA. Licensed CC0.

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