Recall Z-1517-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
| Date | Sep 22, 2015 |
| Status | Terminated |
| Reason | Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation. |
| Root cause | Software design |
| Action | On 9/22/2015, the recalling firm issued letters dated 9/8/2015 and flagged "PRODUCT INFORMATION" via email to their customers. The recalling firm also issued letters dated 3/28/2016 via email the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A letter dated 7/11/2016 was issued to nonresponders. |
| Quantity | 89 sites potentially have the affected software |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051649 | VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 Camtronics Medical Systems, Aug 2, 2005 |