Recall Z-0057-2012 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Sonosite, Inc.
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.
| Date | Oct 18, 2011 (initiated Jul 18, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc., Jan 12, 2005 |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) Sonosite,Inc., Nov 16, 2005 |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM Sonosite,Inc., May 8, 2007 |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc., Aug 25, 2008 |