Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures
Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.
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 2/5 (Moderate).
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. The hazard is a software defect causing data propagation failures, which is a functional issue without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk or voluntary precautionary recalls.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of Merge PACS software. The affected versions are 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, and 7.0.1. 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 and may fail to import on the destination server.
The distribution was made to medical facilities in the USA (nationwide) and internationally to Canada. There was no government or military distribution. Approximately 248 sites potentially have the affected versions.
Medical facilities should contact Merge Healthcare for instructions on how to resolve the issue. The source text does not specify a consumer action for individual patients, as the product is distributed to medical facilities.
The recalled product
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 248
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 (7)
- Versions 6.6.1
- 6.6.1.1
- 6.6.2
- 6.6.2.1
- 6.6.2.2
- 7.0
- and 7.0.1
Distribution
Distributed nationwide across the United States.
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