BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
FDA Recall Z-0005-2011 · Posted 2010-10-04
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Recalling FirmVerathon, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2010-08-23
Date Terminated2011-09-08
Product Quantity260 units
Reason for Recall
The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
Firm Action
Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to:
" Add the enclosed addendum to their current Users Manual.
" Update the application software of the device to v2.7.0 or higher.
If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or
[email protected].
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
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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