Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 a
FDA device recall Z-2061-2011 · posted 2011-04-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letter on July 24, 2009. The letter identified the product, the problem, and the action to be taken by the customer. A software update will be conducted in the field. Until that update occurs, customers were instructed to image without the CW doppler to avoid a system shut down. Customers were instructed to contact their service support person with any questions. For questions regarding this recall call 650-694-5993.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 70 units
- Distribution
- Worldwide Distribution - USA including CA, CT, FL, MA, and TX and the countries of United Arab Emirates, Germany, Ecuador, Spain, France, Great Britian, Saudi Arabia, Sweden, Thailand, and South Afric
- Date initiated
- 2009-07-24
- Date posted
- 2011-04-25
- Date terminated
- 2011-04-25
- 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 |