The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2591-2017·Announced 2017-06-21

Merge Healthcare Recalls Merge PACS Software Due to Image Display Defect

Merge Healthcare is recalling specific versions of Merge PACS software because a display defect may cause image lines to shift, potentially leading to physician misdiagnosis.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of misdiagnosis, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of Merge PACS (Picture Archiving Communication System) software. The software is designed for the soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography. The affected versions are 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2.

The recall is due to a defect where cut lines shown on an image may shift from vertical to horizontal. This visual change may cause confusion for physicians reading the images, which could result in a misdiagnosis.

The affected software is distributed nationwide, and 47 sites have the potentially affected versions. The U.S. Food and Drug Administration has classified this as a Class II recall. Users of the affected software versions should contact Merge Healthcare for further instructions on how to resolve the issue.

The recalled product

Product
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
47

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 7.0.2.1
  • 7.0.2.2
  • 7.0.2.3
  • 7.0.2.3 P1
  • and 7.0.2.3 P2

Distribution

Distributed nationwide across the United States.

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