FDA Device recall Z-0707-2017
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. e…
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. e… by Merge Healthcare, citing 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 displaye….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0707-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-20 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | EFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0707-2017%22
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