DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and in
FDA device recall Z-1385-2017 · posted 2017-03-02 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- The software is not adding the correct tomo image.
- Action taken
- Merge sent an Urgent Medical Device Recall dated July 11, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions send an email to recall@merge.com
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 28 sites potentially have the affected software
- Distribution
- US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
- Date initiated
- 2016-04-08
- Date posted
- 2017-03-02
- Date terminated
- 2017-03-06
- Location
- Hartland, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DR SYSTEMS PACS, RELEASE 6.1 (K041935) | Dr Systems, Inc. | 2004-08-16 |