CIVCO VirtuTRAX Instrument Navigator — Class II medical device recall Z-1952-2012
Terminated recall by Civco Medical Instruments Inc, reported 2012-07-18, distributed in CA, IN, MA, NJ, WA, WI. The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the pro
| Recall number | Z-1952-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Civco Medical Instruments Inc, Kalona, IA, United States |
| Recall initiated | 2012-05-07 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2015-01-07 |
| Distributed | CA, IN, MA, NJ, WA, WI |
| Countries outside the US | CA, DE, DK, FR, HK, IT, JP, KR, UA |
| Quantity | 221 kits |
| Lot numbers | M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840, M790710, M790720, M790730, M790740, M798560, M813890, M840810 |
| Model numbers | 410-240, 5350925 |
Product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
Reason for recall
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1952-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.