Z-0092-06

Sienet Cosmos. Radiological Image Processing. Model number 10018971

Name: Z-0092-06 Sienet Cosmos. Radiological Image Processing. Model number 10018971
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-09-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-09-22 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sienet Cosmos. Radiological Image Processing. Model number 10018971 on 2005-09-22. The reason FDA records is "reference lines appear above actual position". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0092-06
Status: Terminated
Initiated: 2005-09-22
Posted: 2005-10-28
Terminated: 2006-08-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sienet Cosmos. Radiological Image Processing. Model number 10018971
Product code: LLZ System, Image Processing, Radiological
Reason for recall: reference lines appear above actual position
FDA root cause: Other
Action: The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence.
Quantity in commerce: 64 units
Distribution: The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA.
Product codes and lots: model number 10018971 version VB15C

Product code LLZ

K042832Class IISienet Cosmos (Version V15a)Siemens AG Medical Solutions / cleared 2004-10-28

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)