Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinic
FDA device recall Z-1717-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
- Action taken
- Siemens sent an Safety Advisory Notice letter dated May 9, 2014, to affected customer. The letter identified the affected product, problem and actions to be taken. For question call +49 (913) 84-9908.
- Root cause
- Use error
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 433
- Distribution
- US Nationwide
- Date initiated
- 2014-05-09
- Date posted
- 2014-06-04
- Date terminated
- 2015-08-18
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| YSIO (K081722) | Siemens Medical Solutions USA, Inc. | 2008-08-22 |