The Recall Desk

FDA (Devices) recall action 79963

Draeger Medical Systems, Inc. recalled 2 products on 2018-06-13

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
2018-06-13
Critical
0
Units
17,074

Why these products were recalled

Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement

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

  • LowFDA (Devices)··2018-06-13

    Draeger Jaundice Meter JM-103 Recalled for Measurement Display Misinterpretation

    Draeger Medical Systems is recalling the Jaundice Meter JM-103 because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubin
    Category
    Distribution
    51 states
  • LowFDA (Devices)··2018-06-13

    Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings

    Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubine
    Category
    Distribution
    51 states