The Recall Desk
ModerateFDA (Devices)·Z-1431-2017·Announced 2017-03-15

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.

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. 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.
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.