ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 101
FDA device recall Z-1838-2011 · posted 2011-03-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc., Mountain View, CA
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- ITX
- 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, Switzer
- Date initiated
- 2010-08-17
- Date posted
- 2011-03-28
- Date terminated
- 2012-06-18
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON X300 ULTRASOUND SYSTEM (K072676) | Siemens Medical Solutions USA, Inc. | 2007-12-18 |