Merge Healthcare Recalls iConnect Access Software for Patient Data Errors
Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics for studies originating on Merge PACS or Ortho PACS.
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 a direct physical injury mechanism like a broken device or toxic substance, fitting the criteria for a moderate severity software recall.
Plain-English summary
Merge Healthcare, Inc. is recalling iConnect Access software used with Merge PACS. The recall affects iConnect Access V4.0 or earlier with any version of Merge PACS, as well as iConnect Access V4.1 with Merge PACS V6.5.4 or earlier.
The recall is due to a software defect where studies viewed in iConnect Access that originate on Merge PACS or Ortho PACS may not display the correct current patient demographics. This error can occur if a Patient/Study Demographic Edit (PDE) was performed after the images were ingested in the PACS system.
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 potentially have the affected versions of both products. Medical facilities should contact Merge Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- iConnect Access used with Merge 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
- 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.
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