The Recall Desk

FDA (Devices) recall action 78469

GE Medical Systems China Co., Ltd. recalled 2 products on 2018-02-21

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
2018-02-21
Critical
0
Units
10,296

Why these products were recalled

Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.

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

  • HighFDA (Devices)··2018-02-21

    GE Carestation 600 Series Recalled for Possible Incomplete CO2 Seal

    GE Medical Systems is recalling 5,148 Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and the breathing circuit.

    Product
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
    Category
    Distribution
    39 states