The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2590-2017·Announced 2017-06-21

Merge PACS Software Recalled for Potential Image Display Defect

Merge Healthcare is recalling specific versions of Merge PACS software because unviewed images may not display correctly, posing a risk of 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 involves a risk-of-harm product (medical software) where injury (misdiagnosis) has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of Merge PACS software. 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 the software did not show unviewed images when the last view was skipped.

This defect creates a potential risk to patient health because physicians may not have all available images for viewing, which could lead to a misdiagnosis. The software was distributed nationwide in the United States, with no foreign, government, or military distribution. Approximately 47 sites potentially have the affected versions.

Healthcare facilities using these specific versions of Merge PACS software should contact Merge Healthcare for instructions on how to resolve the issue. Consumers and patients should consult their healthcare providers if they have concerns regarding their medical imaging records.

The recalled product

Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
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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