Z-1572-2011

MOSAIQ Oncology Information System

Name: Z-1572-2011 MOSAIQ Oncology Information System
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-01-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-01-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management on 2011-01-11. The reason FDA records is "The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1572-2011
Status: Terminated
Initiated: 2011-01-11
Posted: 2011-03-07
Terminated: 2012-04-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Sent an Urgent Medical Device Correction Safety Advisory Notice to customers on 1/11/11. Letters will be delivered by Siemens Customer Service Group or sent by certified mail. Letter identified the affected product and stated there is a potential risk due to a problem identified by the manufacturer. Customers are asked to refer to the attached Safety Notice from Elekta IMPAC Software. A Siemens Service Engineer will contact customers site to arrange for a patient matching criteria audit to determine if you have a problem. Customers should include the Safety Advisory Notice including the Safety Notice from Elekta IMPAC Software in their product related documentation until further notice. If customers have any questions, they should contact their responsible SIEMENS Service Engineer or Application Specialist.
Quantity in commerce: 10 units
Distribution: International Only Distribution -- Germany and Japan
Product codes and lots: Part # 10568605

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)