Merge — Class II medical device recall Z-0707-2017
Terminated recall by Merge Healthcare, Inc., reported 2016-12-14, distributed nationwide. A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not dis
| Recall number | Z-0707-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-10-20 |
| Classified | 2016-12-05 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2019-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IS, IT, JP, LB, LT, LU, LV, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TR, UA, UY, VN, ZA |
| Quantity | 2,163 |
| Reason classes | labeling |
Product
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians
Reason for recall
A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing.
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-0707-2017. 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.