Merge OrthoCase software — Class II medical device recall Z-0878-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-12-28, distributed in CA, CO, CT, MA, MD, MN, MT, NE…. Measurements in the software are changing after saving a plan with a measurement result, which may result in p
| Recall number | Z-0878-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2015-10-08 |
| Classified | 2016-12-21 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2018-06-22 |
| Distributed | CA, CO, CT, MA, MD, MN, MT, NE, NJ, NV, NY, PA, SC, WA, WI |
| Countries outside the US | CA |
| Quantity | 30 sites |
| Reason classes | software |
Product
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for recall
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
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-0878-2017. 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.