MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows f
FDA device recall Z-1597-2020 · posted 2020-03-26 · Open, Classified
Recall details
- Recalling firm
- Elekta Impac Software
- Reason for recall
- The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
- Action taken
- The firm began notifying their consignee on 09/24/2019 by email. The notice explained the issue and provided a workaround for the consignee to use until the updated software is ready for release.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MUJ
- Quantity affected
- 3732 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2019-09-24
- Date posted
- 2020-03-26
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ ONCOLOGY INFORMATION SYSTEM (K141572) | Impac Medical Systems, Inc. | 2014-09-05 |