Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merge Cardio software. Product Usage: Merge Cardio is a system Recalled by Merge Healthcare, Inc. Due to If a reader selects Multi-study review prior to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.
Affected Products
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information 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.
Quantity: 188 sites potentially have the effected versions
Why Was This Recalled?
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merge Healthcare, Inc.
Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report