The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2686-2016·Announced 2016-09-07

Merge Healthcare Recalls iConnect Enterprise Archive Due to Image Display Issues

Merge Healthcare is recalling iConnect Enterprise Archive software because interventional radiology images are not displaying correctly in RadSuite.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall involves a software display defect without reported injuries or illnesses, fitting the criteria for a moderate severity issue related to product functionality rather than direct physical harm.

Plain-English summary

Merge Healthcare, Inc. is recalling the iConnect Enterprise Archive software. This product is intended for use as a vendor neutral archive for the storage and communications of medical images and data.

The recall is being conducted because interventional radiology (IR) images stored as JPEG2k Lossless in the Merge Enterprise Archive are not displaying correctly in RadSuite.

The affected software versions are 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1. The distribution pattern indicates US distribution to Colorado and Oklahoma, with 96 sites potentially having the affected versions for both products.

The recalled product

Product
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
96

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 (6)

  • Version: 8.80
  • 8.80.0.1
  • 8.80.0.2
  • 8.80.1.1
  • 8.80.2
  • and 8.80.2.1

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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