Merge Healthcare Recalls eFilm Workstation Software Due to Image Selection Error
Merge Healthcare is recalling eFilm Workstation versions 4.0 and 4.0.1 because a software defect may cause users to select the wrong patient study when using the thumbnail panel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical imaging software) where selecting the wrong study could lead to diagnostic errors, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling eFilm Workstation software versions 4.0 and 4.0.1. This software is a component of a Picture Archiving and Communications System (PACS) used to view, store, and process digital medical images from various sources such as CT, MR, and X-ray units.
The recall is due to a software issue that occurs when multiple studies are open and the user utilizes the thumbnail panel to select multiple series. In this specific scenario, the software may lead to the selection of an incorrect study. This could result in a user viewing images that do not correspond to the intended patient or study.
Approximately 2,630 units were distributed worldwide, including in the United States and countries such as Argentina, Australia, Canada, and Germany. Users of this software should contact Merge Healthcare for instructions on how to resolve the issue or obtain an update.
The recalled product
- Product
- eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital…
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 2,630
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- versions 4.0 and 4.0.1
Distribution
Distributed nationwide across the United States.
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