# FDA recall Z-2820-2020

> **89 NORTH** · Class II · device recall initiated 2020-01-31.

## Product

LDI Laser firmware lower than V02.13.00 for   LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6    Laser Science fluorescence imaging

## Reason for recall

The defect relates to firmware version lower than V02.13.00. It is controlling  safety interlocks of the LDI; specifically, the potential for the LDI to enter a service mode intended for use in the factory environment only which overrides all interlocks. When this mode - "Interlock Override Mode" - is entered, the system does not cease laser emission when interlocks are opened, but rather allows emission to continue with open interlocks. The potential for this to occur is non-compliant with 21CFR 1040 .10{f )(2) and 21 CFR 1040 .10(f)(3).

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2820-2020
- **Recalling firm:** 89 NORTH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-31
- **Report date:** 2020-09-02
- **Termination date:** 2023-05-02

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Williston, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2820-2020

## Citation

> AI Analytics. FDA recall Z-2820-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2820-2020. Source: US FDA. Licensed CC0.

---

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