SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to di
FDA device recall Z-1972-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
- Action taken
- Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 5
- Distribution
- US in the states of NC and NE
- Date initiated
- 2015-06-11
- Date posted
- 2015-07-02
- Date terminated
- 2017-03-24
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING (VERSION V31) (K081734) | Siemens AG Medical Solutions | 2008-07-03 |
| SYNGO IMAGING (VERSION V30) (K071114) | Siemens AG Medical Solutions | 2007-05-22 |