Recall Z-0397-2022 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
| Date | Oct 8, 2021 |
| Status | Terminated |
| Reason | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| Root cause | Device Design |
| Action | The firm distributed an "URGENT: MEDICAL DEVICE RECALL" notice on 10/21/2021 by email. The notice explained the problem and requested acknowledgement of the notice. Entities further distributing the products were directed to notify those to whom the devices were distributed. The firm will be replacing the units. |
| Quantity | 18 boxes (5 units/box) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092619 | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER Civco, Nov 13, 2009 |