CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.
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, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Civco Medical Instruments Inc is recalling 100 kits of the CIVCO General Purpose Sensor, a non-sterile reusable electromagnetic sensor used with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers. The affected product is identified by reference number 610-1066 and includes sensor component part number 410-240.
The recall was initiated because the sensors were incorrectly calibrated. This defect may cause potential variability in the projected position of the needle path when used with the ultrasound device. The sensors are intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
The affected units 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. Specific lot numbers involved in the recall include M436540, M468460, M469640, M495160, M495190, M523420, M524580, M555880, M563330, M577940, M590400, M597880, M643870, M673080, M685650, M708280, M717280, M726110, M726130, M736410, M782740, M799860, M817860, and M840610.
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. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part nu
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 100
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 (20)
- Lot numbers M436540
- M468460
- M469640
- M495160
- M495190
- M523420
- M524580
- M555880
- M563330
- M577940
- M590400
- M597880
- M643870
- M673080
- M685650
- M708280
- M717280
- M726110
- M726130
- M736410
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
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