Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 221 VirtuTRAX kits because the electromagnetic sensors were incorrectly calibrated, which may cause variability in projected needle paths.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device defect that could lead to inaccurate needle path projection, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Civco Medical Instruments Inc is recalling 221 kits of the 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.
The recall was initiated because the general purpose electromagnetic sensor was incorrectly calibrated. This defect causes potential variability in the projected position of the needle path with the ultrasound device.
The affected products were distributed worldwide, including in the United States (specifically Wisconsin, California, Massachusetts, Indiana, Washington, and New Jersey) and foreign countries such as Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France. The specific lot numbers involved are M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840, M790710, M790720, M790730, M790740, M798560, M813890, and M840810.
The recalled product
- 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 l
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 221
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot numbers M560850
- M682770
- M725050
- M725060
- M751430
- M753340
- M753350
- M753360
- M753370
- M770940
- M779830
- M779840
- M790710
- M790720
- M790730
- M790740
- M798560
- M813890
- and M840810.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Civco Medical Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Civco Medical Instruments Inc
See all →- HighCivco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks
FDA (Devices) · 2015-04-15
- ModerateCivco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
FDA (Devices) · 2014-09-03
- ModerateCivco Belly Board Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
- ModerateCivco Belly Board MRI Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
- HighCivco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
FDA (Devices) · 2012-07-18
Same hazard · calibration error
See all →- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11