Units with serial numbers ranging from 1000 to 3179 are affected. (Serial number 1564 was not used.) The serial number is assigned as a sequential number, with no breakdown.
Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.
Description du dispositif
The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume.