CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report

Civco General Purpose Sensor recalled by Civco Medical Instruments

Civco Medical Instruments is recalling Civco General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, distributed in California, Indiana, Massachusetts, New Jersey, Washington, Wisconsin. The recall was initiated on 7 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 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.

Quantity recalled100 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1954-2012
FDA event ID: 61793
Recalling firm: Civco Medical Instruments, Kalona, IA
Classification: Class II
Status: Terminated
Recall initiated: 7 May 2012
FDA classified: 6 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

7 May 2012	Recall initiated by company
6 Jul 2012	Classified by FDA	+60 days
18 Jul 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 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

Where it was distributed

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.

California Indiana Massachusetts New Jersey Washington Wisconsin

Stores named: Online Retailers

Questions about this recall

Is Civco General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor recalled?

Yes. Civco Medical Instruments recalled Civco General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor on 7 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1954-2012.

Why was it recalled?

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

Which lots are affected?

Lot numbers 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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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