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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76622

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

Open FDA event record

Event summary

Timeline bucket
January 14, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Med-Hot Thermal Imaging, Inc.

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

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

Z-2057-2017
Recall number
Z-2057-2017
Initiated
January 14, 2017
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Indications for use are not cleared or approved for market in the U.S.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Indications for use are not cleared or approved for market in the U.S.

Code information

P/N 18001-EBT-MP-D with FLIR A315 camera P/N 15102-EBT-MP-D wjth FLIR A615 camera TotalVision Software versions 1.6  1.7.1

Distribution pattern

US: AL and NJ - Foreign: Nigeria