The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0477-2013·Announced 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.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or serious consequences in high-dependency environments are categorized as Severe (Score 4).

Plain-English summary

Arjo, Inc. dba ArjoHuntleigh is recalling the Enterprise 9000 Bed, an AC-powered adjustable hospital bed equipped with a built-in electronic weigh scale, patient bed exit alarm, and under-bed anti-entrapment system. The recall covers Models 9000, 9600, 9700, and 9800, as well as Models 8000, 8001, 8002, 8003, 8500, 8600, 8700, and 8800 with all serial numbers. The affected units are distributed worldwide, including the United States (nationwide, including Puerto Rico), Canada, and numerous other countries.

The recall was initiated after ArjoHuntleigh received reports of unintended movement where the backrest and/or thigh sections of the bed 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 beds are used in general medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care, and oncology settings, particularly for high-dependency patients who pose a movement and handling risk.

Healthcare facilities and users should contact Arjo, Inc. dba ArjoHuntleigh for instructions on how to address the defect. The agency has classified this recall as Class II, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

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…
Manufacturer
Arjo, Inc. dba ArjoHuntleigh
Category
Medical Device — Hospital Bed
Hazard

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 →

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