Merge Cardio recallZ-2403-2020 · Merge Healthcare, Inc. · initiated May 8, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-2403-2020
- Status
- Terminated
- Initiated by the company
- May 8, 2020
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 62 units
- Product code
- LLZ
- FDA submissions
- K051649
- 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 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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Merge Cardio V11.1Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls14 reports
- Merge Cardio 10.3Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls13 reports
- Merge Cardio 11.0Merge Healthcare Solutions Inc. · System, Image Processing, Radiological2 recalls8 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K051649 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Merge Cardio 12.1Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall1 death8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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