Siemens syngo.plaza. Radiological image processing system
FDA device recall Z-2078-2012 · posted 2012-07-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
- Action taken
- Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2
- Distribution
- (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
- Date initiated
- 2012-02-24
- Date posted
- 2012-07-26
- Date terminated
- 2014-01-14
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO. PLAZA VA20A (K101666) | Siemens AG Medical Solutions | 2010-08-10 |