ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound, 1230 Shoreb
FDA device recall Z-2051-2011 · posted 2011-04-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.
- Action taken
- Siemens issued a Customer Safety Advisory Notification letter to all customers on March 15, 2011, regarding a software error on the ACUSON S2000 ultrasound systems affected measurement . They are in the process of releasing a software update that will correct this issue. Siemens recommends reviewing the patient report at the end of each study to confirm that the report contains only measurements relevant to the exam just performed. No patient injury has been reported. Further questions regarding this recall please call (650) 694-5398.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 1533 units
- Distribution
- Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC
- Date initiated
- 2011-03-15
- Date posted
- 2011-04-22
- Date terminated
- 2012-06-18
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |