FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
- Recall number
- Z-1572-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
- Status
- Terminated
- Initiated
- 2011-01-11
- Posted
- 2011-03-07
- Terminated
- 2012-04-19
- Reason
- The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.
- 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
- 10 units
- Distribution
- International Only Distribution -- Germany and Japan
- Lot, serial or model codes
- Part # 10568605
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28