Merge Healthcare, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2403-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

Product Classification:

Class II

Date Initiated: May 8, 2020

Date Posted: July 1, 2020

Recall Number: Z-2403-2020

Event ID: 85633

Reason for Recall:

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.

Status: Terminated

Product Quantity: 62 units

Code Information:

Merge Cardio versions 10.X and 11.X with Knowledge Base versions 3.3, 3.4, 3.5 or 5.0 installed on or before February 21, 2020. Version 10.0 Pre-UDI Application server PN 88-00528-00; Workstation PN:88-00534-00 Version 10.1.2 Pre-UDI Application server PN 88-01075-00; Workstation PN 88-01078-00 Version 10.2 P2 Pre-UDI Application Server PN 88-01203-00 Version 10.2 P1&P2 Pre-UDI Software Release PN 87-00247-00 Version 10.3 UDI: (01) 00842000100041(10)10.3.0.1137(11)170104 Application server PN: 88-01233-00; Workstation PN 88-01239-00 Version 10.3 Patch 1 UDI: (01)00842000100041(10)10.3.0.2009(11)170309 Software Release PN 88-01319-00; Workstation PN: 88-01320-00 Version 10.3.1 UDI: (01) 00842000100041 (10) 10312135 (11) 171024 Application Server PN: 88-01426-00; Workstation PN 88-01430-00 Version 11.0.2 UDI: (01)00842000100416(10)11.0.2.1523(11)180809 Application Server Installation PN: 88-01570-00; Workstation Installation PN 88-01571-00 Version 11.0.3 UDI: (01)00842000100416(10)11.0.3.1601(11)181019 Workstation Installation PN: 88-01589-00 Version 11.1.1 UDI: (01)00842000100751(10)11.1.1(11)190724 Application Server 30-01650-00; Workstation PN:30-01654-00

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated