Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2820-2020 — LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

U.S. FDA — Device Enforcement · United States · 2020-01-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2820-2020
Date of alert
2020-01-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
89 NORTH
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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