Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2057-2017 — 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

U.S. FDA — Device Enforcement · United States · 2017-01-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2057-2017
Date of alert: 2017-01-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Med-Hot Thermal Imaging, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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