Merge Healthcare Fusion Workstation Recalled for Incorrect Hounsfield Measurement Values
Merge Healthcare is recalling Fusion Workstation software because the Hounsfield measurement tool reports incorrect values after extended use.
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 device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling the Fusion Workstation, a medical device indicated for the transmission and review of radiological images. The recall is due to a defect where the Hounsfield measurement tool reports incorrect values after a period of time running the software.
The affected software versions are V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1. Distribution was made to sites in Arizona, California, Idaho, Illinois, Indiana, Michigan, Minnesota, and New Jersey. Approximately 13 sites potentially have the affected version.
The source text does not specify consumer actions or report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Fusion Workstation.; Indicated for the transmission and review of radiological images.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 13
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 (6)
- Versions V3.0.2 P3
- 3.02
- 3.1
- 3.2
- 3.3
- and 3.3.1.
Distribution
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