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89 NORTH recalls LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence im
Recalled September 2, 2020 · FDA recall Z-2820-2020 · 89 NORTH
Hazard
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). · FDA Class II
Units
188
Sold at
Worldwide
Description
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).
Product
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Manufacturer(s)
89 NORTH
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →