ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008
FDA device recall Z-2344-2015 · posted 2015-08-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letters to affected customers via certified mail with return receipt. The letter identified the affected product, problem, potential risk to patients and actions to be taken. Seimens instructed that this notice be shared with all personnel within your organization who need to be aware of this issue. For questions contact your Siemens service representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 4140 total
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Col
- Date initiated
- 2015-06-29
- Date posted
- 2015-08-05
- Date terminated
- 2018-01-18
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (K142876) | Siemens Medical Solutions USA, Inc. | 2014-10-23 |