FDA Device Recall Z-0004-2011: Verathon, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2011.

Recall Res Number

Z-0004-2011

Recalling Firm / Manufacturer

Verathon, Inc.

FEI Number

3022472

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-08-23

Date Posted

2010-10-04

Date Terminated

2011-09-08

Product Code

IYO

Event Number

56411

Product Quantity

73 units

Product Description 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

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 Details 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.

Distribution Pattern Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.

Code Information / Serial Numbers 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.

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Medical Device Recall: Z-0004-2011

Recall Parameters & Description

Related Establishments / Registrations

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