Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imagi
FDA device recall Z-1504-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letter on April 2, 2014 to all affected customers via certified mail. The letter identified the affected product, problem and what actions to take until software is upgraded. For questions call 1-888-826-9702.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 490
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, Franc
- Date initiated
- 2014-04-02
- Date posted
- 2014-04-24
- Date terminated
- 2015-11-12
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM (K123001) | Siemens Medical Solutions USA, Inc. | 2012-10-26 |