Merge OrthoPACS software recalled due to data propagation failures
Merge Healthcare is recalling specific versions of Merge OrthoPACS software because studies may fail to transfer or import correctly between servers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software data propagation failure without explicit reports of patient injury or hospitalization, fitting the criteria for a moderate severity software defect.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of Merge OrthoPACS software. The affected versions are 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2. The software was distributed to medical facilities in the United States, with approximately 160 sites potentially affected.
The recall is due to a defect where studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via the telmed protocol to the destination server. Additionally, these studies may fail to import on the destination server. This issue could result in the loss or failure to transfer specific medical imaging data between systems.
Medical facilities using the affected software versions should contact Merge Healthcare for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 160
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 (5)
- Versions 6.6
- 6.6.1
- 6.6.2
- 6.6.2.1
- and 6.6.2.2
Distribution
Distributed nationwide across the United States.
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