Merge Healthcare Recalls OfficePACS Software Due to Data Loss Risk
Merge Healthcare is recalling OfficePACS software versions 4.0 through 4.2 because a defect in the archiving function may cause potential data loss.
What this means for you
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 is potential data loss, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of its OfficePACS software. The affected software versions are 4.0, 4.1, 4.1.1, 4.1.2, and 4.2. OfficePACS is intended for the manipulation and displaying of medical images by licensed and qualified healthcare professionals.
The recall is being conducted because the software archiving function is not working properly, which may result in potential data loss. The software was distributed nationwide to medical facilities, with no government, military, or foreign distribution. A total of 216 sites have the affected software.
Healthcare facilities using the affected software should contact Merge Healthcare, Inc. for further instructions on how to address the archiving defect and prevent data loss.
The recalled product
- Product
- Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and i
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 216
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 (5)
- Software versions: 4.0
- 4.1
- 4.1.1
- 4.1.2
- and 4.2
Distribution
Distributed nationwide across the United States.
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