Siemens syngo Imaging XS. Radiological image processing system.
FDA device recall Z-1064-2012 · posted 2012-02-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisor
- Action taken
- Siemens Medical issued an "UPDATE INSTRUCTIONS SY055/11/S/UPDATE PACKAGE VA70B_0211" to all affected customers. The package described the product, problem, and instructions for customers to follow.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 128
- Distribution
- Nationwide Distribution-including the states of CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
- Date initiated
- 2012-01-26
- Date posted
- 2012-02-20
- Date terminated
- 2012-09-29
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |