The Recall Desk

FDA (Devices) recall action 90250

Getinge Usa Sales Inc recalled 2 products on 2022-06-29

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
2022-06-29
Critical
0
Units
64

Why these products were recalled

Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

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

  • SevereFDA (Devices)··2022-06-29

    Anesthesia System Suction Switch Crack Recall: Potential Equipment Failure

    Getinge is recalling 17 Flow-c Anesthesia Systems due to cracks that may develop on the suction unit's on/off switch, potentially preventing the switch from activating and posing a risk to patients.

    Product
    Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
    Category
    Distribution
    6 states
  • SevereFDA (Devices)··2022-06-29

    Anesthesia system suction switch may crack and fail to activate

    Getinge Flow-e Anesthesia System units may have a crack forming on the suction unit's on/off switch, which could break and prevent the suction from being activated, potentially harming patients.

    Product
    Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
    Category
    Distribution
    6 states