ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of l
FDA device recall Z-1077-2013 · posted 2013-04-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 101
- Distribution
- Worldwide Distribution
- Date initiated
- 2012-12-20
- Date posted
- 2013-04-10
- Date terminated
- 2013-07-19
- Location
- Martinez, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ ONCOLOGY INFORMATION SYSTEM (K123230) | Impac Medical Systems, Inc. | 2012-12-12 |