Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and
FDA device recall Z-1778-2017 · posted 2017-04-11 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
- Action taken
- MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-5369.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 24 sites potentially have the affected versions
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
- Date initiated
- 2016-04-04
- Date posted
- 2017-04-11
- Date terminated
- 2019-02-21
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSUITE HEMODYNAMICS 7.10 (K082421) | Emageon, Inc. | 2008-12-17 |