# FDA recall Z-0324-2024

> **Convergent Dental** · Class II · device recall initiated 2023-09-01.

## Product

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal  CUS-00226 Rev. K reworked

## Reason for recall

It has been found that potential unintended laser activation can occur without foot pedal depression.

## Distribution

Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.

## Key facts

- **Recall number:** Z-0324-2024
- **Recalling firm:** Convergent Dental
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-01
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Needham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2024

## Citation

> AI Analytics. FDA recall Z-0324-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0324-2024. Source: US FDA. Licensed CC0.

---

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