Device recall: Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002…
Class II FDA enforcement event 63187. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Arjo, Inc. dba ArjoHuntleigh started this device recall on 16 Nov 2012. The firm address in the FDA record is in Addison, IL. FDA put the recall in Class II. FDA event 63187 has 2 product records. The first FDA enforcement report date is 14 Aug 2013. The record gives the status Terminated, with the termination date 13 Sep 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile,…
Recalling firm
Arjo, Inc. dba ArjoHuntleigh, Addison, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0476-2013 | 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… | 94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW | Class II | Terminated | 14 Aug 2013 |
| Z-0477-2013 | 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, care of the elderly, HDU, ITU, coronary… | 1,324 beds in USA, 138 beds in Canada, 1,877 beds ROW | Class II | Terminated | 14 Aug 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Jun 2017 | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Throm | Device | Class II | 1 |
| 21 Dec 2015 | The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents i | Device | Class II | 1 |
| 21 Jan 2013 | Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Mode | Device | Class II | 1 |
| 10 Dec 2012 | Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Swe | Device | Class II | 1 |
| 29 Jun 2012 | Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Model | Device | Class II | 3 |
Official channels
- FDA enforcement report Z-0476-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 63187. https://recallregister.com/fda/ii/63187/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution-USA (nationwide, including Puerto Rico) and the countries of Algeria, Angola, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovia, Botswana, Brazil, Canada, Chile,…
- What quantity of product is in FDA event 63187?
- The event has 2 product records. The first record gives this quantity:
94 beds in U.S., 31 beds in Canada, 26,010 beds in ROW
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.