FDA Device recall Z-0878-2017
Merge OrthoCase software
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Merge OrthoCase software by Merge Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0878-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-08 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | CA, CO, CT, MA, MD, MN, MT, NE, NJ, NV, NY, PA, SC, WA, WI |
Product
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason
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.
Identifiers
| code_info | Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.…Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Merge Healthcare
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0878-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.