The Recall Desk

FDA (Devices) recall action 63187

Arjo, Inc. dba ArjoHuntleigh recalled 2 products on 2013-08-14

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
2013-08-14
Critical
0
Units
—

Why these products were recalled

ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing the control button. These incidents have occurred in High Dependency and Intensive Therapy environments where unintended movement of the patient may have serious consequences.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2013-08-14

    ArjoHuntleigh Recalls Enterprise 8000 Hospital Beds Due to Unintended Movement

    ArjoHuntleigh is recalling Enterprise 8000 hospital beds because the backrest or thigh sections may move without user input, posing a risk to patients in high-dependency care.

    Product
    Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is…
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2013-08-14

    Arjo Enterprise 9000 Hospital Beds Recalled for Unintended Movement

    ArjoHuntleigh is recalling Enterprise 9000 hospital beds because the backrest or thigh sections may move without user input, posing a risk to patients in high-dependency care.

    Product
    Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery…
    Category
    Distribution
    1 state