Agency classClass IIOur severity:High FDA (Devices)·Z-1697-2017·Announced 2017-04-05

Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Data Access Issues

Merge Healthcare is recalling iConnect Enterprise Archive software because archived studies cannot be opened or sent to PACS, preventing physicians from reviewing comparison studies.

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 device software) where the inability to access comparison studies could impact clinical decision-making, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Merge Healthcare, Inc. is recalling iConnect Enterprise Archive (ICEA) software. The software is intended for use as a vendor-neutral archive for the storage and communication of medical images and data. The recall affects specific versions of the software, including 8.30, 8.40, 8.70, 8.80, 9.0, 9.1, 9.2, 9.3, and 9.4 series.

The recall is due to a defect where archived studies cannot be opened in iConnect Access and cannot be sent to PACS. This issue results in comparison studies not being available for physician review to determine the progression of disease.

Approximately 298 sites potentially have the affected versions, with 290 of those sites located in the United States. The software was distributed worldwide, including in the US, Canada, Belgium, Australia, Jordan, and the UK. Users should contact Merge Healthcare for further instructions on resolving the issue.

The recalled product

Product: iConnect Enterprise Archive (ICEA) software. 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 — Software
Hazard: data-access-failure
clinical-decision-impairment

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
8.40.2
8.40.2.1
8.40.2.2
8.70
8.80
8.80.0.1
8.80.0.2
8.80.1.1
8.80.2
9.0.0
9.0.0.1
9.1.0
9.1.1
9.1.2
9.1.2.1
9.2.0

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

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