Recall Z-2820-2020 ยท REK Research Laser
89 NORTH
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
| Date | Jan 31, 2020 |
| Status | Terminated |
| 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). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | All customers who purchased an LOI prior to identification of the defect were notified of the defect electronically per the email address on record for each customer. Each affected LOI was identified by serial number per our production records. 2. The firmware upgrade was distributed to all affected customers via the electronic notification. A website link embedded in the electronic notification brings customers to an electronic form where they are asked to submit their contact information as well as the serial numbers of the LDI units they are upgrading. 3. Upon completing the form, the u |
| Quantity | 188 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.