Recall Z-2403-2020 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, t
| Date | May 8, 2020 |
| Status | Terminated |
| Reason | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative. |
| Root cause | Software Design Change |
| Action | IBM Watson Health Imaging, also known as Merge Healthcare, sent an "Urgent Field Safety Notice" on May 6, 2020. The letter states that it is safe to continue to use the device as is, with the understanding that the Z-Score ranges are incorrect and should not be used to make clinical determinations. Z-Scores can be removed upon request by contacting Customer Support at the contact information below. The will provide a software correction to address the issue. A representative will be in contact with distributors to ensure all affected units have been updated. All potential users of Merge Car |
| Quantity | 62 units |
| Distribution | US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT. |
| 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 |