89 NORTH: Medical Device Recall in 2020 - (Recall #: Z-2820-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 31, 2020

Date Posted: September 2, 2020

Recall Number: Z-2820-2020

Event ID: 86158

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).

Status: Terminated

Product Quantity: 188

Code Information:

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

Distribution Pattern:

Worldwide

Voluntary or Mandated:

FDA Mandated