Device Recall syngo.plaza 의 리콜

Recall

62679

Class 2

Z-2275-2012

2012-07-18

2012-08-27

Terminated

United States

2014-01-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111341

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.