The Recall Desk

FDA (Devices) recall action 93463

ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalled 2 products on 2024-01-03

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
2024-01-03
Critical
0
Units
929

Why these products were recalled

Unintended movement of bed wheels

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)··2024-01-03

    Arjo Medical Beds Recalled Due to Unintended Wheel Movement

    Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2024-01-03

    Arjo medical beds with unintended wheel movement recalled

    Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.

    Product
    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
    Category
    Distribution
    7 states