Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2685-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 30, 2016

Date Posted: September 7, 2016

Recall Number: Z-2685-2016

Event ID: 74924

Reason for Recall:

Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.

Status: Terminated

Product Quantity: 96 sites potentially have the affected versions for both products

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.

Voluntary or Mandated:

Voluntary: Firm initiated