CLASS II Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

LDI Laser firmware lower than V02.13.00 for LDI recalled by 89 North

89 North is recalling LDI Laser firmware lower than V02.13.00 for LDI. The recall was initiated on 31 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLDl-7, LDI-WF, LDI-NIR, LDl-6

Quantity recalled188

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2820-2020
FDA event ID: 86158
Recalling firm: 89 North, Williston, VT
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2020
FDA classified: 25 Aug 2020
Reported: 2 Sep 2020
Type: FDA Mandated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

31 Jan 2020	Recall initiated by company
25 Aug 2020	Classified by FDA	+207 days
2 Sep 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging

Where it was distributed

Worldwide

Questions about this recall

Is LDI Laser firmware lower than V02.13.00 for LDI recalled?

Yes. 89 North recalled LDI Laser firmware lower than V02.13.00 for LDI on 31 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-2820-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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