—#48861

Product

Sienet Sky, picture archiving and communications system. Model number 8463163

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K935694
Affected lot / code info: Model number 8463163, all versions.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: The product was shipped to medical facilities nationwide.

Timeline

Recall initiated: 2006-09-05
Posted by FDA: 2006-10-25
Terminated: 2008-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48861. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.