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.
FDA Recall Z-1939-2009 · Posted 2009-09-17
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Recalling FirmVerathon, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2009-05-18
Date Terminated2010-10-07
Product Quantity1,978
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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