Z-2403-2020Class II

Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation...

Name: Z-2403-2020 Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation...
Creator: Merge Healthcare, Inc.
Published: 2020-05-08
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2020-05-08 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system... on 2020-05-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2403-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-08
Posted: 2020-06-19
Terminated: 2023-06-23
Recalling firm: Merge Healthcare Incorporated
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 [email protected] or 877-741-5369.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2403-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2403-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-19

Product code LLZ

K051649Class IIVericis Cardiovascular Image and Information System, Model 4.0Camtronics Medical Systems / cleared 2005-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)