TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitomet
FDA device recall Z-0369-2017 · posted 2016-11-05 · Terminated
Recall details
- Recalling firm
- Medimaps Group
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KGI
- Quantity affected
- 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, Lit
- Date initiated
- 2016-10-03
- Date posted
- 2016-11-05
- Date terminated
- 2017-06-07
- Location
- Plan-les-Ouates, Switzerland
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TBS iNsight (K152299) | Medimaps Group SA | 2016-04-29 |