Reported Sep 2, 2020 · Terminated
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
89 North
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: 89 NORTH · 20 Winter Sport Ln · Williston, VT · 05495-8144
Is this the product you have?
- LDI Laser firmware lower than V02.13.00
- for LDI modelsLDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
- Lot codes and dates
- LDl-7, LDI-WF, LDI-NIR, LDl-6
- Amount recalled
- 188
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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