Agency classClass IIOur severity:Severe FDA (Devices)·Z-0878-2017·Announced 2016-12-28

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: measurement-error
patient-injury
delayed-diagnosis
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

Distributed in 15 states:

Same manufacturer · Merge Healthcare, Inc.

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