Recall Z-0003-2011
Verathon, Inc. · initiated August 23, 2010
Product
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Codes / lots: Serial numbers: B6001061, B6001062, B6001063, B6001064, B6001065, B6001066, B6001067, B6001068, B6001069, B6001070, B6001071, B6001072, B6001073, B6001074, B6001075, B6001076, B6001077, B6001078, B6001079, B6001080, B6001081, B6001082, B6001083, B6001084, B6001085, B6001086, B6001088, B6001090, B6001092, B6001093, B6001097, B6001098, B6001103, B6001104, B6001107, B6001108, B6001109, B6001110, B6001111, B6001112, B6001113, B6001134, B6001164, B6001166, B6001167, B6001168, B6001169, B6001170, B6001172, B6001173, B6001174, B6001175, B6001176, B6001177, B6001178, B6001179, B6001181, B6001184, B6001185, B6001186, B6001187, B6001188, B6001189, B6001190, B6001191, B6001192, B6001198, B6001199, B6001200, B6001201, B6001202, B6001203, B6001204, B6001205, B6001206, B6001207, B6001208, B6001209, B6001211, B6001212, B6001213, B6001215, B6001216, B6001217, B6001218, B6001219, B6001220, B6001221, B6001223, B6001224, B6001225, B6001232, B6001233, B6001234, B6001239, B6001240, B6001242, B6001243, B6001244, B6001245, B6001251, B6001253, B6001254, B6001255, B6001256, B6001257, B6001258, B6001259, B6001260, B6001261, B6001263, B6001265, B6001267, B6001269, B6001270, B6001271, B6001272, B6001273…
Reason for recall
The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
FDA-determined cause: Software design
Action taken
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 cservice@verathon.com.
Details
- Recall number
- Z-0003-2011
- Initiated
- August 23, 2010
- Posted by FDA
- October 4, 2010
- Terminated
- September 8, 2011
- Product code
- IYO – System, Imaging, Pulsed Echo, Ultrasonic
- Quantity
- 351 units
- Distribution
- Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
- Recalling firm
- Verathon, Inc., Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0004-2011 | AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects…The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file… | 08/23/2010Terminated |
| Z-0005-2011 | BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy…The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file… | 08/23/2010Terminated |