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CIVCO General Purpose Sensor, Non-sterile reusable general… recallZ-1953-2012 · Civco Medical Instruments Inc · initiated May 7, 2012

Class II Terminated All recalls posted in July 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Civco Medical Instruments Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-1953-2012
Recall class
Class II
Status
Terminated
Initiated by the company
May 7, 2012
Posted by the FDA
Jul 6, 2012
Recalling firm
Civco Medical Instruments Inc
Quantity
30 kits
Product code
IYO
FDA submissions
K092619
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.

Product description

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

Code information (models, lots, serial numbers)

Lot numbers M867430 and M873080

Other devices under the same FDA submission

12 devices cleared under K092619 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 61793).

Sources and updates

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