syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, r

FDA device recall Z-1622-2014 · posted 2014-05-16 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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.

Action taken

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. .

Root cause

Use error

Status

Terminated

Product code

LLZ

Quantity affected

64

Distribution

Nationwide Distribution

Date initiated

2014-04-03

Date posted

2014-05-16

Date terminated

2014-12-15

Location

Malvern, PA

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