Food, drugs, devices › Merge Healthcare, Inc.
Device recall: Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc. (Hartland, WI) initiated this device recall on 4 Apr 2016; FDA lists 1 product record under event 76260, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 8 Apr 2019. Initiation: voluntary: firm initiated. Merge Healthcare, Inc. has 84 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Merge Healthcare, Inc., Hartland, WI.
Reason for recall
"Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment."
Distribution
"Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1176-2017 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | 29 sites have the potentially affected software | Class II | Terminated | 15 Feb 2017 |
Context
Other enforcement events for Merge Healthcare, Inc.
All 84 events for Merge Healthcare, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.