Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 1
FDA device recall Z-2065-2011 · posted 2011-04-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Software Error with potential for misinterpretation of data-- The previous patient's last capture clip image can appear in the next patient's study.
- Action taken
- The firm, Siemens, sent a "CUSTOMER SAFETY ADVISORY NOTIFICATION" letter to its customers on July 30, 2009. The letter described the product, problem and actions to be taken. The customers were instructed they need to update any of the patient registration settings to reset the cine buffer so that no data is transferred between studies, if the system software is not being updated. Siemens informed the customers that a mandatory update software is being installed on their system free of charge. If you have any questions, contact (650) 969-9112.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 2312 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries including: Albania, algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile,China, C
- Date initiated
- 2009-07-30
- 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 |