# FDA recall Z-1074-2022

> **Daavlin Distributing Company** · Class II · device recall initiated 2022-04-26.

## Product

4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v.  M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

## Reason for recall

Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of  Australia, Canada.

## Key facts

- **Recall number:** Z-1074-2022
- **Recalling firm:** Daavlin Distributing Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-26
- **Report date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bryan, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1074-2022

## Citation

> AI Analytics. FDA recall Z-1074-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1074-2022. Source: US FDA. Licensed CC0.

---

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