Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager), image-intensified fluorosc
FDA device recall Z-2787-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a potential hazard to staff or patients when lowering the table height on the Ysio system. If staff or patients lower extremities are placed underneath the table and the user lowers the table top, it is possible that parts of the table may collide with extremities and cause injuries.
- Action taken
- Siemens sent a Safety Advisory Notice to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to place the Safety Notice in the System's instruction for use. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner. Customers were instructed to complete the Acknowledgement of Receipt Form and return to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 141
- Distribution
- Nationwide Distribution including Washington, DC and the following States: AR, CA, CO, FL, ID, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, a
- Date initiated
- 2011-04-28
- Date posted
- 2011-07-11
- Date terminated
- 2014-04-10
- 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 |