AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen t
FDA device recall Z-0004-2011 · posted 2010-10-04 · Terminated
Recall details
- Recalling firm
- Verathon, Inc.
- Reason for recall
- The AortaScan AMI 9700 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 73 units
- Distribution
- Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
- Date initiated
- 2010-08-23
- Date posted
- 2010-10-04
- Date terminated
- 2011-09-08
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 (K082456) | Verathon Incorporated | 2008-12-01 |