Z-0369-2017Class II

TBS iNsight Version v.3.0.1

Name: Z-0369-2017 TBS iNsight Version v.3.0.1
Creator: Medimaps Group
Published: 2016-10-03
License: https://open.fda.gov/license/

Medimaps Group SA / initiated 2016-10-03 / Terminated

FDA source

Medimaps Group began a recall of 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... on 2016-10-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0369-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-03
Posted: 2016-11-05
Terminated: 2017-06-07
Recalling firm: Medimaps Group SA
Product: 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.
Product code: KGI Densitometer, Bone
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Medimaps sent an Urgent Field Safety Notice letter dated October 3, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 15 units in US
Distribution: Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
Product codes and lots: Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0369-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0369-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-05

Product code KGI

K152299Class IITBS iNsightMedimaps Group SA / cleared 2016-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)