89 NORTH recalls LDI Laser models with firmware versions older than V02.13.00 due to potential safety interlock failure. This could allow laser emission when safety interlocks are opened, violating federal regulations.
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).
89 NORTH is recalling LDI Laser models with firmware versions older than V02.13.00. The defect could allow the laser to emit light even when safety locks are open, creating a risk of injury if the device is used improperly.
The firmware defect allows the laser to enter a factory-only service mode that disables safety interlocks. When this happens, the laser can continue emitting light even if safety locks are opened, which could cause injury if the device is used incorrectly.
Users of LDI Laser models LDl-7, LDI-WF, LDI-NIR, and LDl-6 with firmware versions older than V02.13.00 are affected. Those using the devices in environments where safety interlocks are critical, such as medical or industrial settings, face the highest risk.
Check if your LDI Laser model (LDl-7, LDI-WF, LDI-NIR, or LDl-6) has firmware version older than V02.13.00. The recall covers devices sold with firmware versions below this specific version number.
Look for the firmware version on your device's settings menu or documentation to confirm it is at least V02.13.00.
If your firmware is older than V02.13.00, contact 89 NORTH for a firmware update to resolve the safety issue.
LDI models LDl-7, LDI-WF, LDI-NIR, and LDl-6 with firmware versions older than V02.13.00.
The older firmware can cause the laser to enter a factory service mode that disables safety interlocks, allowing the laser to emit light when safety locks are open.
Check your device's settings menu or documentation for the firmware version; it must be at least V02.13.00 to be safe.
We’ve drafted a message you can send 89 NORTH to request your refund or repair — edit it as you like.
Subject: Recall Z-2820-2020 — 89 NORTH 89 NORTH Hello, I own a 89 NORTH that is covered by recall Z-2820-2020 from 89 NORTH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
