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

Recall number

Z-2403-2020

Recalling firm

Merge Healthcare, Inc.

Product

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.

Status

Terminated

Initiated

2020-05-08

Posted

not on file

Terminated

2023-06-23

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 Cardio versions 10.X and 11.X with Pediatric Echo Knowledge Base with Michigan or Hybrid Z-Scores versions 3.3, 3.4, 3.5 or 5.0 should receive the notice. Customers with questions regarding the notice, please contact Customer Support at WHISupport@us.ibm.com or 877-741-5369.

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.

Lot, serial or model codes

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

510(k) numbers

["K051649"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

1000116130

Firm city

Hartland

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy