Merge OrthoCase software recall due to measurement errors
Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall with potential for patient injury or delay in diagnosis/treatment, meeting the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge OrthoCase software. The recall affects versions 2.0 through 3.7.3, including specific sub-versions listed in the agency notice. The software was distributed to medical facilities in 15 US states and to Canada and other foreign countries.
The recall was initiated because measurements in the software change after saving a plan with a measurement result. This defect may result in potential patient injury or delay in diagnosis or treatment. Approximately 30 sites potentially have the affected versions.
Medical facilities should contact Merge Healthcare for instructions on how to address the software defect. Consumers are not directly affected as this is a medical device software product used by healthcare professionals.
The recalled product
- Product
- Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 30
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: 2.0
- 2.1
- 2.1.1
- 3.1
- 3.2
- 3.2.4
- 3.3
- 3.3.1
- 3.4
- 3.5.1
- 3.5.1.1
- 3.5.2
- 3.5.3
- 3.5.4
- 3.5.5
- 3.6
- 3.6.1
- 3.6.2
- 3.7
- 3.7.1
Distribution
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