Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute,
FDA device recall Z-2794-2016 · posted 2016-09-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
- Action taken
- Siemens mailed to customers on August 04, 2016 a Customer Advisory Notice that provided interpretations about the meaning of measurement values like area, distance and perimeter shown as "o.p." by the syngo.plaza.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 101 Systems
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-08-02
- Date posted
- 2016-09-14
- Date terminated
- 2017-03-20
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO.PLAZA VB10A (K132532) | Siemens AG Healthcare | 2013-12-09 |