Z-0004-2011

AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the...

Name: Z-0004-2011 AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the...
Creator: Verathon, Inc.
Published: 2010-08-23
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2010-08-23 / Terminated / root cause: software

FDA source

Verathon, Inc. began a recall of AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal... on 2010-08-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0004-2011
Status: Terminated
Initiated: 2010-08-23
Posted: 2010-10-04
Terminated: 2011-09-08
Recalling firm: Verathon Inc.
Product: AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design
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].
Quantity in commerce: 73 units
Distribution: Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
Product codes and lots: Serial numbers: A7001001, A7001005, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001048, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001062, A7001065, A7001066, A7001067, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001093, A7001094, A7001095, A7001096, A7001097, A7001098, A7001099, A7001100, A7001101, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001133, A7001134, A7001135, A7001136, A7001138, and A7001139.

Product code IYO

K082456Class IIVerathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated / cleared 2008-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)