Civco General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.
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 (variability in needle path projection) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Civco Medical Instruments Inc is recalling 30 kits of the CIVCO General Purpose Sensor, Ref. 10441627. These non-sterile, reusable electromagnetic sensors are used with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
The recall was initiated because the sensors were incorrectly calibrated. This defect causes potential variability in the projected position of the needle path when used with the ultrasound device.
The affected products are Lot numbers M867430 and M873080. Distribution was worldwide, including the United States (specifically WI, CA, MA, IN, WA, and NJ) and foreign countries such as Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France. Users should stop using the affected sensors and contact the manufacturer for instructions.
The recalled product
- Product
- CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part numb
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 30
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 (1)
- Lot numbers M867430 and M873080
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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