Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors
Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.
What this means for you
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 incorrect measurements could impact patient care, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Merge Healthcare, Inc. is recalling eFilm Workstation and eFilm Lite software 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. The recall involves 2,163 units distributed worldwide, including the United States and numerous international locations. The software is used by medical professionals to view, process, and display digital medical images from various sources.
The recall is due to a product issue affecting RF projection images. When users perform measurements on these images, the '.cal' (Calibration) label is not displayed, even though it should be present if the measurement is based on Pixel Spacing. Consequently, the measurements displayed may not be correct. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Affected users are trained medical professionals, including radiologists, technologists, and clinicians. The source text does not provide specific instructions for consumers or end-users on how to resolve the issue, but the recall is managed by Merge Healthcare, Inc.
The recalled product
- 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, com
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 2,163
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 (10)
- 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.
Distribution
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