The Recall Desk

FDA (Devices) recall action 68756

Philips Ultrasound, Inc. recalled 2 products on 2014-07-30

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
2014-07-30
Critical
0
Units
—

Why these products were recalled

The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2014-07-30

    Philips QLAB 10 Core Module Software Recall for Measurement Defect

    Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.

    Product
    QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2014-07-30

    Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect

    Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.

    Product
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Distribution
    10 states