Merge Healthcare CADstream software recall for missing PURE filter message
Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.
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 is classified as FDA Class II. The hazard involves a risk of incorrect patient follow-up, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling CADstream software versions prior to 5.2.9. The recall is due to a software defect where the PURE filter user interface message does not display on DICOM transfer studies. This issue occurs when a site begins using the PURE filter.
The failure to display the user interface message may result in incorrect patient follow-up. The affected software was distributed worldwide, including nationwide in the USA, as well as to foreign, military, and government entities. Approximately 844 sites potentially have the affected versions.
Healthcare facilities should contact Merge Healthcare for information on how to resolve the software issue. Consumers are not directly affected by this recall, as the product is medical software used by healthcare providers.
The recalled product
- Product
- CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 844
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 prior to 5.2.9
Distribution
Distributed nationwide across the United States.
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