The Recall Desk

FDA (Devices) recall action 74924

Merge Healthcare, Inc. recalled 2 products on 2016-09-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-09-07
Critical
0
Units
192

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-09-07

    Merge Healthcare Recalls RadSuite Software Due to Image Display Errors

    Merge Healthcare is recalling RadSuite software versions 8.30.6 through 8.30.6.3 because interventional radiology images are not displaying correctly.

    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.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2016-09-07

    Merge Healthcare Recalls iConnect Enterprise Archive Due to Image Display Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because interventional radiology images are not displaying correctly in RadSuite.

    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.
    Category
    Distribution
    2 states