Syngo Imaging XS 의 리콜

Recall

53563

Class 2

Z-0271-2010

2009-11-16

Terminated

United States

2012-07-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85876

Distorted image. the "distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.

The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.