Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: February 15, 2017 Initiated: November 17, 2015 #Z-1180-2017
Product Description
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 8 sites have the potentially affected version
- Distribution
- US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 8 sites have the potentially affected version.
Why was this product recalled? ▼
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Moderate. Recall number: Z-1180-2017.
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