Civco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
Civco Medical Instruments is recalling 24 VirtuTRAX Instrument Navigator kits because incorrect sensor calibration may cause variability in projected needle paths during ultrasound procedures.
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 risk of harm due to inaccurate tracking of needle paths, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Civco Medical Instruments Inc is recalling 24 kits of the CIVCO VirtuTRAX Instrument Navigator, Ref. 610-1080. The product includes a reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm), and five telescopically-folded CIV-Flex sensor covers. The kits are intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
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 when used with an ultrasound device.
The affected kits were distributed worldwide, including in the United States (Wisconsin, California, Massachusetts, Indiana, Washington, and New Jersey) and in Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France. The specific lot numbers involved are M493010, M493220, M708150, M710060, M783360, M803040, M803520, M808870, M823690, M832260, M840620, M848450, M855680, and M871810. Healthcare facilities should stop using the affected sensors and contact the manufacturer for instructions on return or replacement.
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. 610-1080. The firm name on the
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 24
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 (14)
- Lot numbers M493010
- M493220
- M708150
- M710060
- M783360
- M803040
- M803520
- M808870
- M823690
- M832260
- M840620
- M848450
- M855680
- and M871810.
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.
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