Z-0069-2007

Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969

Name: Z-0069-2007 Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
Creator: Siemens Medical Solutions USA, Inc
Published: 2006-10-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2006-10-03 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969 on 2006-10-03. The reason FDA records is "Potential loss of images. Images may not successfully be sent to the RAID system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0069-2007
Status: Terminated
Initiated: 2006-10-03
Posted: 2006-10-25
Terminated: 2008-04-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential loss of images. Images may not successfully be sent to the RAID system.
FDA root cause: Other
Action: The recalling firm has issued a software patch to resolve the issue via Update Instructions HS110/06/S. The Update Instructions direct a Siemens Service Representative to visit the affected sites, install the software patch to resolve the issue, and hand deliver a Customer Advisory Notice, dated September 20th, 2006, to the customer to notify them of the issue.
Quantity in commerce: 5 units
Distribution: The product was shipped to hospitals in CA, MD, MO, and PA
Product codes and lots: Model number 10018969. Serial numbers 1001, 1010, 1011, 1028, 1029

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)