Home / Recalls / 89 NORTH / Z-2820-2020

Z-2820-2020 Class II Terminated

Recalled by 89 NORTH — Williston, VT

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
January 31, 2020
Termination Date
May 2, 2023
Voluntary/Mandated
FDA Mandated
Product Quantity
188

Product Description

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 Pattern

Worldwide

Code Information

LDl-7, LDI-WF, LDI-NIR, LDl-6