Merge Healthcare Recalls LIS Software Due to Duplicate Container Numbers
Merge Healthcare is recalling Merge LIS software versions 4.0.1 and earlier because the software may create duplicate container numbers for patients.
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 medical device software defect that could lead to patient safety issues, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge LIS software versions 4.0.1 and earlier. The recall is being conducted because the software has a potential to create duplicate container numbers for patients.
The affected software was distributed nationwide and to the Virgin Islands, with foreign distribution to the Bahamas. The source indicates that 413 sites potentially have the affected software.
Healthcare facilities using this software should contact Merge Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- Merge LIS software.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 413
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: 4.0.1 and earlier.
Distribution
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