The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, t
FDA device recall Z-1086-2015 · posted 2015-02-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
- Action taken
- Consignees were not notified of this issue.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 719 systems (global)
- Distribution
- Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM
- Date initiated
- 2012-10-23
- Date posted
- 2015-02-10
- Date terminated
- 2016-12-23
- Location
- Hoffman Estates, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIEMENS ENHANCED IMAGING SYSTEM (K041166) | Siemens Medical Solutions USA, Inc. | 2004-05-17 |