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.
What this means for you
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.
- 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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