Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2532-2016·Announced 2016-08-24

Merge Healthcare Recalls iConnect Access Software Due to Patient Data Errors

Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics after edits, potentially affecting medical specialists.

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 is classified as FDA Class II. The hazard involves incorrect patient data display, which is a significant software defect but does not involve direct physical injury or death, fitting the criteria for a moderate severity recall involving data integrity issues.

Plain-English summary

Merge Healthcare, Inc. is recalling iConnect Access software used with Ortho PACS. The recall is due to a defect where studies viewed in iConnect Access may not display the correct current patient demographics if a Patient/Study Demographic Edit (PDE) was performed after the images were ingested in the PACS system.

The affected products include iConnect Access V4.0 or earlier used with any version of Ortho PACS, and iConnect Access V4.1 used with Ortho PACS V5.1.2 and earlier. Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution. Approximately 146 sites may have the affected version for both products.

Medical specialists using this software should be aware that patient demographic information may be outdated or incorrect. Users should verify patient demographics through other reliable sources to ensure accurate patient identification and data integrity.

The recalled product

Product: iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: data-integrity
mis-labeling
Affected units: 146

Distribution

Distributed nationwide across the United 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 →

Same manufacturer · Merge Healthcare, Inc.

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