The Recall Desk
ModerateFDA (Devices)·Z-2301-2016·Announced 2016-08-10

Merge PACS software recall for missing patient data in telmed studies

Merge Healthcare is recalling specific versions of Merge PACS software because studies received via telmed were missing patient DOB, procedure, and referring physician information.

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 hazard involves missing administrative data (DOB, procedure, physician) rather than a direct physical injury or high-risk pathogen. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving data integrity or labeling issues.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of Merge PACS software. The software is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. The recall involves versions V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.

The recall was initiated because studies coming over via telmed were missing the patient's date of birth, procedure, and referring physician. This data omission could impact the accuracy of patient records and clinical workflows.

The affected software was distributed worldwide, including in the USA, New Zealand, and the United Kingdom. A total of 109 sites have the affected versions. Users of the software should contact Merge Healthcare for further instructions on how to resolve the data integrity issue.

The recalled product

Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
109

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 (12)

  • Versions: V6.0 MR4 CU 1-11
  • 6.1.0
  • 6.1.1
  • 6.1.1.1
  • 6.1.2
  • 6.1.3
  • 6.1.3.1
  • 6.2.0
  • 6.2.1
  • 6.2.2
  • 6.2.2.1
  • and 6.2.3.

Distribution

Distribution scope not specified by the agency.

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