Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA device recall Z-1403-2017 · posted 2017-03-03 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
- Action taken
- Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 110 sites potentially have the affected versions
- Distribution
- Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
- Date initiated
- 2016-04-04
- Date posted
- 2017-03-03
- Date terminated
- 2019-07-26
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 (K051649) | Camtronics Medical Systems | 2005-08-02 |