Recall Z-1838-2011 ยท ITX Transducer, Ultrasonic, Diagnostic
Siemens Medical Solutions USA, Inc., Mountain View, CA
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 U
| Date | Mar 28, 2011 (initiated Aug 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | 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. |
| Distribution | 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-F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072676 | ACUSON X300 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Dec 18, 2007 |