The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0614-2017·Announced 2016-11-30

Merge Healthcare Recalls RadSuite Software Due to Image Display Malfunction

Merge Healthcare is recalling RadSuite software versions 8.30.7.8 through 8.31 because images may not appear readable, potentially delaying care or causing patient re-exposure to radiation.

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 the source text explicitly states the malfunction has the potential to result in delay in care and possible re-exposure to radiation, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Merge Healthcare, Inc. is recalling 29 units of Merge RadSuite software, formerly known as Emageon Advanced Visualization. The affected software versions are 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. This software is used to distribute, display, and store diagnostic-quality medical images in electronic format, including 2D and 3D radiological images.

The recall was initiated after a customer reported that RadSuite images were not appearing as readable images. This malfunction has the potential to result in a delay in patient care and a possible re-exposure of the patient to radiation (x-ray).

The affected software was distributed nationwide, including in Alabama, California, Florida, Indiana, Michigan, Missouri, New York, Pennsylvania, Tennessee, and Wisconsin. Users of the affected software versions should contact Merge Healthcare for further instructions on how to resolve the issue.

The recalled product

Product
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time…
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
29

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 (4)

  • RadSuite versions 8.30.7.8
  • 8.30.7.9
  • 8.30.8
  • and 8.31

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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