FDA Medical Device Recalls (openFDA)
Civco Medical Instruments Inc: 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 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
- Recall number
- Z-1953-2012
- Recalling firm
- Civco Medical Instruments Inc
- 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 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
- Status
- Terminated
- Initiated
- 2012-05-07
- Posted
- 2012-07-06
- Terminated
- 2015-01-07
- Reason
- The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
- Root cause
- Component design/selection
- Action
- CIVCO sent an Urgent Medical Device Recall letter dated May 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return all general purpose sensors as the product may not function as intended. To return the affected product customers should contact the OEM Sales Coordinator at 319-248-6521 to schedule the return of their device. Upon receipt of the snesor, CIVCO will arrange for recalibration. Once recalibration is completed, the sensor will be returned to the customer at no charge. Customers were asked to forward this communication to all their customers who purchased the affected product. Once CIVCO has received the customer list, they will contact the end-user to request they return their general purpose sensor directly to CIVCO for recalibration. For questions customers should call 800-441-6741. For questions regarding this recall call 319-656-4447.
- Quantity
- 30 kits
- Distribution
- Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.
- Lot, serial or model codes
- Lot numbers M867430 and M873080
- 510(k) numbers
- ["K092619"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 1937223
- Firm city
- Kalona
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28