syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Recall
- Recall Number
- Z-1622-2014
- Event Number
- 68107
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Use error
- Initiated
- April 3, 2014
- Posted
- May 16, 2014
- Terminated
- December 15, 2014
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355
Description
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.
Siemens sent a Customer Safety Advisory Notice dated April 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our service organization already checked all syngo Imaging sites and did not find any other occurrence of the wrongly configured link. Additionally our service organization will include the check for such wrongly configured links into the existing proactive site monitoring procedures. We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your personnel accordingly. Please include this safety advisory notice in your operator's manual. In the interests of safety, we ask that you perform the above preventive measures and inform all affected personnel immediately. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (610) 219-6300. .
Nationwide Distribution
64