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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79628

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

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Event summary

Timeline bucket
January 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
NeuroLogica Corporation

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

Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical

Z-1391-2018
Recall number
Z-1391-2018
Initiated
January 12, 2018
Classification
Class II
Status
Terminated
Recalling firm
NeuroLogica Corporation
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.

Code information

Model Number GMR40. Serial numbers 00001 through 00016.

Distribution pattern

US Distribution . Only one consignee was shipped 16 units of the affected device.