The Recall Desk

FDA (Devices) recall action 72661

Merge Healthcare, Inc. recalled 2 products on 2016-01-06

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
2016-01-06
Critical
0
Units
3

Why these products were recalled

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

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)··2016-01-06

    Merge Hemo Software Recalled Due to Incomplete Validation

    Merge Healthcare is recalling Merge Hemo software version 10.0 LA because it was distributed to three customers before being fully validated in-house.

    Product
    Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
    Category
    Distribution
    3 states