Siemens Medical Solutions USA, Inc Sienet Sky, picture archiving and communications system. Model number 8463163 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sienet Sky, picture archiving and communications system. Model number 8463163
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model number 8463163, all versions.
Products Sold
Model number 8463163, all versions.
Siemens Medical Solutions USA, Inc is recalling Sienet Sky, picture archiving and communications system. Model number 8463163 due to Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
Recommended Action
Per FDA guidance
The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026