LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAPhilips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A2026-05-26
- FDAPhilips Avalon Fetal Monitor, FM 30 Part numberM2703A2026-05-26
- FDADigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.2026-05-01
- FDAPhilips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.2026-04-14
- FDAPhilips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.2026-04-14
- FDAPhilips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.2026-04-14
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