Z-1956-2012Class II

CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR...

Name: Z-1956-2012 CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR...
Creator: Civco Medical Instruments Inc
Published: 2012-05-07
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2012-05-07 / Terminated / root cause: design

FDA source

Civco Medical Instruments Inc began a recall of CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator... on 2012-05-07. FDA classified it as Class II and gives the reason as "The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1956-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-07-06
Terminated: 2015-01-07
Recalling firm: CIVCO Medical Instruments Co., Inc.
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 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
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: 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 tag: design
FDA 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 in commerce: 24 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.
Product codes and lots: Lot numbers M493010, M493220, M708150, M710060, M783360, M803040, M803520, M808870, M823690, M832260, M840620, M848450, M855680, and M871810.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1956-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1952-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1953-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1954-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1955-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1956-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code IYO

K092619Class IIEtrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal TrackerCivco / cleared 2009-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)