Device recall: Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.…
Class II FDA enforcement event 62116. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
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 29 Jun 2012. The firm address in the FDA record is in Addison, IL. FDA put the recall in Class II. FDA event 62116 has 3 product records. The first FDA enforcement report date is 18 Jul 2012. The record gives the status Terminated, with the termination date 13 Mar 2018.
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) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great…
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
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1947-2012 | Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for… | 2,552 units in the U.S., 4,970 units in the rest of the world | Class II | Terminated | 18 Jul 2012 |
| Z-1948-2012 | Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate… | 1,989 units in the U.S., 1,626 units in the rest of the world | Class II | Terminated | 18 Jul 2012 |
| Z-1949-2012 | Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus… | 2480 units in U.S., 2,651 units in the rest of the world | Class II | Terminated | 18 Jul 2012 |
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
- 3Median 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 |
| 16 Nov 2012 | Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 80 | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-1947-2012The 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 62116. https://recallregister.com/fda/ii/62116/. 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) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great…
- What quantity of product is in FDA event 62116?
- The event has 3 product records. The first record gives this quantity:
2,552 units in the U.S., 4,970 units in the rest of the world
- 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.