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 appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Arjo, Inc. dba ArjoHuntleigh
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
Product Codes/Lot Numbers:
Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800; all serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0476-2013
Related Recalls
Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. The loop of the sling could potentially come out of the hooks if positioned in the upper portion of the hooks.