Recall Z-2820-2020— 89 NORTH
Class II · Terminated
Class II FDA medical device recall by 89 NORTH, initiated 2020-01-31, terminated 2023-05-02. FDA's recall record names no specific 510(k) clearance for this event. 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: 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)..
- Recalling firm
- 89 NORTH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-31
- Terminated
- 2023-05-02
- Firm location
- Williston, VT, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.