Recall Z-0729-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Cardio software. 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 | Mar 28, 2016 |
| Status | Terminated |
| Reason | If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient). |
| Root cause | Software design |
| Action | MERE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers via email or via certified mail if they did not have an email address for the customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to respond to the notification using the enclosed form and the return addressed envelope. Customers were also instructed to ensure that all users of the product are provided with the notification and if product was further distributed customers need to identify their customers and notify them |
| Quantity | 198 sites potentially have the effected versions |
| Distribution | 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 |