U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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
Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Tanzania, Uganda, United Arab Emirates, Viet Nam, and Zambia.
제품 설명
MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. || General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.