ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816, 10563788; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Recall
- Recall Number
- Z-1838-2011
- Event Number
- 56840
- Firm
- Siemens Medical Solutions USA, Inc., Mountain View, CA 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043
- FEI Number
- 2936884
- Product Code
- ITX
- Status
- Terminated
- Root Cause
- Software change control
- Initiated
- August 17, 2010
- Posted
- March 28, 2011
- Terminated
- June 18, 2012
Description
ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816, 10563788; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.
Siemens Medical Solutions USA, Inc., sent a Customer Safety Advisory Notification letter on August 17, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the notice on to all those within their organization who need to aware of the issue until the corrective action was completed. For questions customers were to contact their local service support person. For questions regarding this recall call 650-694-5993.
Worldwide Distribution - USA (nationwide)and the countries of Antares distribution includes: United Arab Emirates-AE, Austria-AT, Australia-AU, Azerbaijan-AZ, Brazil-BR, Belarus-BY, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Egypt-EG, Spain-ES, France-FR, Great Britain-GB, Guatemala-GT, Croatia-HR, Hungary-HU, Indonesia-ID, Ireland-IE, India-IN, Italy-IT, Jordan-JO, Japan-JP, South Korea-KR, Moldova-MD, Mexico-MX, Malaysia-MY, Netherlands NL, Norway-NO, New Zealand-NZ, Poland-PL, Portugal-PT, Romania-RO, Serbia-RS, Russian Federation-RU, Saudi Arabia-SA, Sweden-SE, Singapore-SG, Slovak Republic-SK, Suriname-SR, Turkey-TR, Taiwan-TW, Ukraine-UA, United States-US, Uruguay-UY, Uzbekistan-UZ, Venezuela-VE, Vietnam-VN, South Africa-ZA S2000 distribution includes: Austria-AT, Australia-AU, Brazil-BR, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Spain-ES, Finland-FI, France-FR, Great Britain-GB, Hong Kong-HK, Indonesia-ID, India-IN, Italy-IT, Japan-JP, South Korea-KR, Kazakhstan-KZ, Lebanon-LB, Mexico-MX, Norway-NO, Philippines-PH, Poland-PL, Portugal-PT, Romania-RO, Russian Federation-RU, Sweden-SE, Slovak Republic-SK, Turkmenistan-TM, Turkey-TR, Taiwan-TW, United States-US X300 distribution includes: AE (United Arab Emirates) , AL (Albania) , AN (Netherlands Antilles), AO (Angola), AR (Argentina), AT (Austria), AU (Australia), AZ (Azerbaijan), BA (Bosnia-Herzegovina), BD (Bangladesh), BE (Belgium), BG (Bulgaria), BN (Brunei), BO (Bolivia), BR (Brazil), BY (Belarus), CA (Canada), CH (Switzerland), CL (Chile), CN (China), CO (Colombia), CV (Cape Verde), CZ (Czech Republic), DE (Germany), DK (Denmark), DZ (Algeria), EC (Ecuador), EG (Egypt), ES (Spain), ET (Ethiopia), FJ (Fiji), FR (France), GB (United Kingdom), GE (Georgia), GR (Greece), HK (Hong Kong), HN (Honduras), HR (Croatia), HU (Hungary), ID (Indonesia), IE (Ireland), IN (India), IR (Iran), IT (Italy), JO (Jordan), JP (Japan), KE (Kenya), KR (Korea, South), KW (Kuwait), KZ (Kazakhstan), LT (Lithuania), LV (Latvia), LY (Libya), MD (Moldova), ME (Montenegro), MK (Macedonia), MM (Myanmar), MU (Mauritius), MX (Mexico), MY (Malaysia), NG (Nigeria), NI (Nicaragua), NL (Netherlands), NO (Norway), NP (Nepal), NZ (New Zealand), PE (Per¿), PH (Philippines), PK (Pakistan), PL (Poland), PS (Palestine), PT (Portugal), QA (Qatar), RS (Serbia), RO (Romania), RU (Russia), RW (Rwanda), SA (Saudi Arabia), SC (Seychelles), SE (Sweden), SG (Singapore), SI (Slovenia), SK (Slovakia), SV (El Salvador), SY (Syria), TH (Thailand), TM (Turkmenistan), TN (Tunisia), TR (Turkey), TT (Trinidad/Tobago), TW (Taiwan, ROC), UA (Ukraine), US (United States of America), UY (Uruguay), UZ (Uzbekistan), VE (Venezuela), VN (Viet Nam), YE (Yemen), ZA and (South Africa)