Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0072-2007

Sienet Magic View 300, picture archiving and communications system. Model numbers 10014063 and 10014064

Siemens Medical Solutions USA, Inc. / initiated 2006-09-05 / Terminated

Siemens Medical Solutions USA, Inc began a recall of Sienet Magic View 300, picture archiving and communications system. Model numbers 10014063 and 10014064 on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0072-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Sienet Magic View 300, picture archiving and communications system. Model numbers 10014063 and 10014064
Product code
LLZ System, Image Processing, Radiological
Reason for recall
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.
FDA root cause
Other
Action
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.
Quantity in commerce
1818 units total, for all three products
Distribution
The product was shipped to medical facilities nationwide.
Product codes and lots
Model numbers 10014063 and 10014064, all versions.