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

Recall Z-0369-2017 — TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

U.S. FDA — Device Enforcement · Switzerland · 2016-10-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0369-2017
Date of alert: 2016-10-03
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Medimaps Group
Product category: device
Product type: Devices

Reported risk: The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.

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

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Recall Z-0369-2017 — TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

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