Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy
Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.
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 medical device software defect that leads to inaccurate clinical data (calcium scores), which poses a risk of harm through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling the Merge Unity Z3D software, version 11.0. This software is part of the Merge Unity PACS system, which is used to manage and view medical images from various diagnostic imaging systems.
The recall is due to a defect in the software's ability to calculate calcium scores. Specifically, the software is unable to accurately determine the calcium score for scans that have a slice thickness not equal to 3 mm. This inaccuracy could lead to incorrect clinical assessments for patients whose scans do not meet the specific 3 mm thickness requirement.
The affected software version is distributed in the United States to sites in California, Pennsylvania, Texas, and Montana. Approximately 9 sites potentially have the affected version. Healthcare facilities using this software should verify their version and consult with Merge Healthcare for guidance on correcting the issue or managing patient data.
The recalled product
- Product
- Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging sys
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 9
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)
- Version 11.0
Distribution
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