The Recall Desk

FDA (Devices) recall action 74734

Merge Healthcare, Inc. recalled 2 products on 2016-08-24

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
2016-08-24
Critical
0
Units
292

Why these products were recalled

Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.

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.

1–2 of 2

  • ModerateFDA (Devices)··2016-08-24

    Merge Healthcare Recalls iConnect Access Software Due to Patient Data Errors

    Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics after edits, potentially affecting medical specialists.

    Product
    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-24

    Merge Healthcare Recalls iConnect Access Software for Patient Data Errors

    Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics for studies originating on Merge PACS or Ortho PACS.

    Product
    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
    Category
    Distribution
    0 states