FDA Recall
Terminated
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Recall: Z-1077-2013
·
Initiated December 20, 2012
Recall
- Recall Number
- Z-1077-2013
- Event Number
- 63974
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2937457
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 20, 2012
- Posted
- April 10, 2013
- Terminated
- July 19, 2013
- Address
- 757 Arnold Dr, Ste A, Martinez, CA, 94553-3615
Description
ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Reason
A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
Action
Siemens sent an Urgent Medical Device Correction letter with update instructions to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your responsible Siemens Service Engineer or Application Specialist.
Distribution
Worldwide Distribution
Quantity
101