U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Ultrasonic pulsed echo imaging system - Product Code IYO
원인
Three specific issues are being addressed:
1. calculation and use of an incorrect year in dates after 12/31/2009.
2. double scans, continuous scans, and double printing.
3. calibration sensitivity.
조치
U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading.
Canadian customers were phoned by Verathon.
For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia.
Contact Verathon Customer Care at 1-800-331-2313 if you have any questions.
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.
제품 설명
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.