Enterprise 8000 Bed — Class II medical device recall Z-0476-2013
Terminated recall by Arjo, Inc. dba ArjoHuntleigh, reported 2013-08-14, distributed nationwide. ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed
| Recall number | Z-0476-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjo, Inc. dba ArjoHuntleigh, Addison, IL, United States |
| Recall initiated | 2012-11-16 |
| Classified | 2013-08-06 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2016-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, KE, KW, LB, LK, LT, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PL, QA, RO, SA, SG, SI, TH, TR, UY, VE, ZA |
| Model numbers | 8000, 8001, 8002, 8003, 8500, 8600, 8700, 8800 |
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 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0476-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.