Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare,
FDA device recall Z-3105-2017 · posted 2017-08-18 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Action taken
- MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-912-3514.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 98 sites have the potentially affected software
- Distribution
- Nationwide Distribution
- Date initiated
- 2017-08-14
- Date posted
- 2017-08-18
- Date terminated
- 2019-05-08
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DR Systems Zero Download 3D Viewer (Z3D) (K143318) | Dr Systems, Inc. | 2015-03-10 |
| DR SYSTEMS PACS, RELEASE 6.1 (K041935) | Dr Systems, Inc. | 2004-08-16 |