Agency classClass IIOur severity:Severe FDA (Devices)·Z-0476-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious consequences for patients in high-dependency environments due to unintended mechanical movement, fitting the criteria for significant injury risk.

Plain-English summary

Arjo, Inc. dba ArjoHuntleigh is recalling the Enterprise 8000 Bed, an AC-powered adjustable hospital bed. The recall covers Models 8000, 8001, 8002, 8003, 8500, 8600, 8700, and 8800 with all serial numbers. The company has received reports of unintended movement where the backrest and/or thigh sections moved without anyone consciously pressing the control button.

These incidents have occurred in High Dependency and Intensive Therapy environments. In these settings, unintended movement of the patient may have serious consequences. The beds are used in general medicine, surgery, care of the elderly, HDU, ITU, coronary care, and oncology, and are appropriate for high-dependency patients who pose a movement and handling risk.

The recall affects 94 beds in the U.S., 31 beds in Canada, and 26,010 beds in the rest of the world. Distribution was worldwide, including the United States (nationwide, including Puerto Rico) and numerous other countries. Healthcare facilities should contact ArjoHuntleigh for instructions on how to address the defect.

The recalled product

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…
Manufacturer: Arjo, Inc. dba ArjoHuntleigh
Category: Medical Device — Hospital Bed
Hazard: unintended-movement
patient-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

Models 8000
8001
8002
8003
8500
8600
8700 and 8800
all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Arjo, Inc. dba ArjoHuntleigh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Arjo, Inc. dba ArjoHuntleigh

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Arjo Enterprise 9000 Hospital Beds Recalled for Unintended Movement
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Same hazard · unintended movement