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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86158

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 31, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
89 NORTH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2820-2020
Recall number
Z-2820-2020
Initiated
January 31, 2020
Classification
Class II
Status
Terminated
Recalling firm
89 NORTH
Quantity
188

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
defect relates to firmware

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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

Distribution pattern

Worldwide

Field note

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