Merge Healthcare recalls specific software versions due to potential inaccurate Z-Score calculations that could lead to false negative results in medical testing. Affected users should check their software versions and contact the company for guidance.
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.
Take action
Contact the company
📍Recalling firmMerge Healthcare, Inc.900 Walnut Ridge Dr · Hartland, WI 53029-8347
“Merge Healthcare Software Recall: Inaccurate Z-Score Calculations Risk False Negatives.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65198-merge-healthcare-software-recall-inaccurate-z-score-calculations-risk-false. Based on FDA recall #Z-2403-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2403-2020%22&limit=1).
The FDA announced on May 8, 2020, that Merge Healthcare, Inc. is recalling Merge Healthcare Merge Application Server Software and Merge Cardio Workstation Software due to a calculation error that may produce inaccurate Z-Scores. The agency classified the recall as Class II.
How to tell if you have it
Brand: Merge Healthcare
Product: Merge Application Server Software Release and Merge Cardio Workstation Software
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.
Context
GovInfoNow's records show Merge Healthcare, Inc. has 11 other recalls on record since June 13, 2017. Other recent recalls include Merge PACS Workstation Software Inaccurate Measurements (July 22, 2026) and Merge PACS Workstation Recalls: Patient Study Thumbnails Display Issue (June 30, 2026). Other recent recalls of similar products include GE Healthcare Workflow Core Services V8 Recall (July 31, 2026), GE Healthcare Enterprise Archive V8 Software Recall (July 31, 2026), and GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (July 31, 2026).
How to tell if you have this one
Check if your software includes Merge Cardio Workstation versions 10.X or 11.X with Knowledge Base versions 3.3, 3.4, 3.5, or 5.0 installed before February 21, 2020. The product codes (PN) listed in the recall details can help identify affected units.
Brand
Merge Healthcare
Product
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your software version by checking the product codes (PN) listed in the recall notice, such as 88-00528-00 for version 10.0.
Contact Manufacturer
Reach out to Merge Healthcare for guidance on whether your software version is affected and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, Georgia, Illinois, Indiana, Missouri, New Mexico, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Vermont, Virginia.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2403-2020 (May 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2403-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.