Device Recall CIVCO General Purpose Sensor 의 리콜

Recall

61793

Class 2

Z-1955-2012

2012-05-07

2012-07-06

Terminated

United States

2015-01-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109101

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

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.