The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1700-2017·Announced 2017-04-05

Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Image Display Issues

Merge Healthcare is recalling iConnect Enterprise Archive software versions that may fail to display prior medical images, potentially delaying treatment.

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. The hazard involves a risk of harm (delay in treatment) due to a software defect, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Merge Healthcare, Inc. is recalling iConnect Enterprise Archive software. The recall affects specific versions of the software, including 5.30.0 through 9.4.3, which are used in medical facilities to store and display medical images.

The recall is being conducted because the affected software versions allow images to be stored without pixel data. This defect results in the system being unable to present all prior studies. The inability to view complete medical history could cause a delay in treatment when determining the progression of disease.

Approximately 371 sites potentially have the affected software. Distribution was nationwide to medical facilities, as well as to Canada, other foreign countries, and government and military entities. Users should contact Merge Healthcare for further instructions on how to address the software defect.

The recalled product

Product
iConnect Enterprise Archive software.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Medical Software
Hazard
Affected units
371

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 (20)

  • Versions 5.30.0
  • 5.30.1
  • 5.30.2
  • 5.30.2 SB0344
  • 5.30.3
  • 5.30.4
  • 5.30.4 HF0418E
  • 5.30.5
  • 5.30.5 HF0404E
  • 5.30.5 HF0413E
  • 5.30.5 HF390E
  • 5.30.5 SB0368
  • 5.30.6
  • 5.30.6 HF0405E
  • 5.30.6 HF0406E
  • 5.30.7
  • 5.30.7 HF0429E
  • 5.30.7 HF0441E
  • 5.30.7 HF0446E
  • 5.30.7 HF0470E

Distribution

Distributed nationwide across the United States.

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