MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. General purpose ultrasound s

FDA device recall Z-0057-2012 · posted 2011-10-18 · Terminated

Recall details

Recalling firm

Sonosite, Inc.

Reason for recall

This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment.

Action taken

The firm SonoSite, Inc., sent an "Urgent - Medical Device Correction" letter dated September 29, 2011 to its foreign and domestic customers. The letter described the product, problem, and actions to be taken. The customers were instructed to follow the three (3) steps provided in the letter to verify if the extended OB/GYN Calculations (EOBC) is enabled on their system. Additionally, SonoSite will perform a software upgrade to M-Turbo and/or MicroMax ultrasound system in order resolve the issue. The customers were instructed to contact Sonosite Technical Support via website: www.sonosite.com/sdratio; email: regulatory@sonosite.com (include contact information and address), or call in U.S. and Canada: 1-877-590-4982. If you have any questions or concerns regarding this matter, do not hesitate to contact in US and Canada at 1-877-657-8118, Monday-Friday, 6 am-5 pm PST. Customer can also send an email to Technical Support at service@sonosite.com

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

4236 units (US) and 4089 units (internationally)

Distribution

Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cypr

Date initiated

2011-07-18

Date posted

2011-10-18

Date terminated

2012-09-14

Location

Bothell, WA

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