Sienet Magic View 300, picture archiving and communications system. Model numbers 10014063 and 10014064
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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
