Home / Recalls / Civco Medical Instruments Inc / Z-1956-2012

Z-1956-2012 Class II Terminated

Recalled by Civco Medical Instruments Inc — Kalona, IA

Recall Details

Product Type
Devices
Report Date
July 18, 2012
Initiation Date
May 7, 2012
Termination Date
January 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24 kits

Product Description

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

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.

Distribution Pattern

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.

Code Information

Lot numbers M493010, M493220, M708150, M710060, M783360, M803040, M803520, M808870, M823690, M832260, M840620, M848450, M855680, and M871810.

Other recalls by Civco Medical Instruments Inc

  • Z-1400-2015 Class II — CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopic (February 26, 2015)
  • Z-2558-2014 Class II — CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/ (August 1, 2014)
  • Z-0803-2014 Class II — Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion (October 25, 2013)
  • Z-0802-2014 Class II — Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, R (October 25, 2013)
  • Z-1952-2012 Class II — CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose drive (May 7, 2012)
  • Z-1953-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)
  • Z-1954-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)
  • Z-1955-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)