Z-0071-2007

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

Name: Z-0071-2007 Sienet Sky, picture archiving and communications system. Model number 8463163
Creator: Siemens Medical Solutions USA, Inc
Published: 2006-09-05
License: https://open.fda.gov/license/

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

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sienet Sky, picture archiving and communications system. Model number 8463163 on 2006-09-05. 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 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0071-2007
Status: Terminated
Initiated: 2006-09-05
Posted: 2006-10-25
Terminated: 2008-09-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sienet Sky, picture archiving and communications system. Model number 8463163
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 number 8463163, all versions.

Product code LLZ

K935694Class IISienet Diagnostic Reporting Console Va02 UpgradeSiemens Medical Solutions USA, Inc. / cleared 1994-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)