ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens
FDA device recall Z-1962-2014 · posted 2014-07-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: To avoid the potential risk of this issue, do not use the Auto-Stats tool; use alternate measurement tools. Only use the Velocity tool on frozen images. Customer Service Engineer will contact the customer to schedule an appointment to replace their existing version of software, free of charge. Customers with questions should contact their local service support person for information regarding timelines and status. Customers were instructed to share this information with all personnel within their organization who need to be aware of this issue. For questions regarding this recall call 650-694-5135.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 790 units
- Distribution
- Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Den
- Date initiated
- 2014-06-03
- Date posted
- 2014-07-01
- Date terminated
- 2016-05-25
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S1000 / S2000 / S3000 (K132804) | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-10-24 |