RadSuite software — Class II medical device recall Z-2627-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-31, distributed in AL, AZ, CA, IL, MA, MD, MI, MO…. Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the view
| Recall number | Z-2627-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-31 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-02-10 |
| Distributed | AL, AZ, CA, IL, MA, MD, MI, MO, NC, NJ, NV, OH, PA, TN, VA |
| Quantity | 25 sites |
Product
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2627-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.