FDA Device recall Z-1952-2012
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX…
- FDA Device
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX… by Civco Medical Instruments, citing the general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1952-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-07 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Civco Medical Instruments |
| Distribution | CA, IN, MA, NJ, WA, WI |
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
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Identifiers
| code_info | Lot numbers M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840,…Lot numbers M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840, M790710, M790720, M790730, M790740, M798560, M813890, and M840810. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1952-2012%22
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