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U.S. Department of Health and Human Services

Class 2 Device Recall Verathon BladderScan BVI 9400

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 Class 2 Recall
Verathon BladderScan BVI 9400
see related information
Date Posted September 17, 2009
Recall Status1 Terminated on October 07, 2010
Recall Number Z-1939-2009
Recall Event ID 52769
Premarket Notification
510(K) Number
K071217 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Verathon, Inc.
20001 N Creek Pkwy
Bothell, Washington 98011-8218
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 1,978
Distribution Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = VERATHON INCORPORATED
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