Device product
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Z-2685-2016
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-2685-2016
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: Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3
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.