Device product
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.
Z-2686-2016
Product summary
- Event
- Event 74924
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 sites potentially have the affected versions for both products
- Official record key
device-enforcement:Z-2686-2016
Official wording
Reason: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Code information: Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
Distribution pattern: US Distribution to: CO and OK.
Derived failure modes
-
Unknown
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.