The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2303-2016·Announced 2016-08-10

Merge PACS Software Recall for Annotation Display Defect

Merge Healthcare is recalling Merge PACS 6.0 software because it fails to display annotations on certain loaded studies.

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, but the source text describes a software display defect without reporting any injuries, illnesses, or deaths. Per the rubric, this aligns with a moderate severity score for a defect where harm has not been reported.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge PACS 6.0 software, a medical device intended to create and display two-dimensional and three-dimensional images of anatomy from digitally acquired images. The recall involves specific versions of the software, including V6.5.5 through 6.6.2.

The recall is due to a software defect where annotations are not displayed when a prior study is loaded, even if the study should contain them. While migrated studies with annotations display correctly, subsequent studies fail to show these annotations. This issue affects 208 sites worldwide, including the United States, Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.

Healthcare facilities using the affected versions should contact Merge Healthcare for instructions on how to resolve the issue. The defect may impact the visibility of clinical annotations during image review.

The recalled product

Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software 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
208

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 (9)

  • Versions: V6.5.5
  • 6.5.6
  • 6.5.7
  • 6.5.8
  • 6.5.9
  • 6.6.0
  • 6.6.1
  • 6.6.1.1
  • 6.6.2

Distribution

Distributed nationwide across the United States.

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