iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: November 23, 2016 Initiated: May 25, 2016 #Z-0611-2017
Product Description
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 60 sites potentially have the affected versions
- Distribution
- Distribution was made to medical facilities nationwide. Foreign distribution was also made.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 60 sites potentially have the affected versions.
Why was this product recalled? ▼
Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0611-2017.
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