89 North LDI Laser Firmware Recall for Safety Interlock Defect
89 North is recalling 188 LDI laser units worldwide due to a firmware defect that allows laser emission to continue when safety interlocks are opened.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (laser safety interlock failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
89 North is recalling 188 units of LDI Laser fluorescence imaging systems, including models LDI-7, LDI-WF, LDI-NIR, and LDI-6, that are running firmware versions lower than V02.13.00. The recall is due to a defect in the firmware that controls the device's safety interlocks.
The defect allows the system to enter a service mode intended only for factory use, which overrides all safety interlocks. In this mode, the laser continues to emit even when interlocks are opened, creating a potential safety hazard. This condition is non-compliant with 21 CFR 1040.10(f)(2) and 21 CFR 1040.10(f)(3).
The affected units were distributed worldwide. Users of these specific LDI models should check their firmware version and contact 89 North for instructions on updating the firmware to version V02.13.00 or higher to resolve the safety interlock issue.
The recalled product
- Product
- LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
- Manufacturer
- 89 NORTH
- Category
- Medical Device — Laser Imaging
- Affected units
- 188
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- LDl-7
- LDI-WF
- LDI-NIR
- LDl-6
Distribution
Distribution scope not specified by the agency.
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