LDI Laser firmware lower than V02 — Class II medical device recall Z-2820-2020
Terminated recall by 89 NORTH, reported 2020-09-02. The defect relates to firmware version lower than V02.13.00. It is controlling safety interlocks of the LDI; s
| Recall number | Z-2820-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | 89 NORTH, Williston, VT, United States |
| Recall initiated | 2020-01-31 |
| Classified | 2020-08-25 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2023-05-02 |
| Quantity | 188 |
| Reason classes | software |
| Model numbers | LDL-6, LDL-7 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2820-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.