The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1762-2017·Announced 2017-04-19

Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Display Error

Merge Healthcare is recalling iConnect Enterprise Archive software because an error message can prevent users from viewing prior studies. The recall affects 333 sites nationwide and internationally.

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, which corresponds to a High severity score (3) under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Merge Healthcare, Inc. is recalling iConnect Enterprise Archive (ICEA) software due to a software error. The defect can cause an error message to appear, resulting in prior studies being unavailable for viewing.

The affected software versions include 8.30, 8.30.2, 8.40.0, 8.40.1, 8.40.1 HF0557, 8.40.s, 8.40.2.1, 8.40.2.2, 8.80, 8.80.0.1, 8.80.1.1, 8.80.2, 8.80.0.2, 9.0.0, 9.0.0.1, 9.1.0, 9.1.1, 9.1.2, 9.1.2.1, 9.1.2.2, 9.2.0, 9.3.0, 9.3.1, 9.4.0, 9.4.1, 9.4.2, 9.4.2.1, and 9.4.3. The firm name on the labeling is Merge Healthcare, Hartland, WI.

Distribution was made nationwide to medical facilities, as well as to Canada, other countries, and government/military entities. Approximately 333 sites potentially have the affected versions. The FDA has classified this as a Class II recall.

The recalled product

Product
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Medical Software
Hazard
Affected units
333

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 : 8.30
  • 8.30.2
  • 8.40.0
  • 8.40.1
  • 8.40.1 HF0557
  • 8.40.s
  • 8.40.2.1
  • 8.40.2.2
  • 8.80
  • 8.80.0.1
  • 8.80.1.1
  • 8.80.2
  • 8.80.0.2
  • 9.0.0
  • 9.0.0.1
  • 9.1.0
  • 9.1.1
  • 9.1.2
  • 9.1.2.1
  • 9.1.2.2

Distribution

Distributed nationwide across the United States.

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