iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
Reported: September 7, 2016 Initiated: January 30, 2016 #Z-2686-2016
Product Description
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
Reason for Recall
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 96 sites potentially have the affected versions for both products
- Distribution
- US Distribution to: CO and OK.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.. Recalled by Merge Healthcare, Inc.. Units affected: 96 sites potentially have the affected versions for both products.
Why was this product recalled? ▼
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2686-2016.
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