# FDA recall Z-2885-2020

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2020-07-08.

## Product

System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147

## Reason for recall

During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.

## Distribution

US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV

## Key facts

- **Recall number:** Z-2885-2020
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-07-08
- **Report date:** 2020-09-02

- **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-2885-2020

## Citation

> AI Analytics. FDA recall Z-2885-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2885-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*