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Leckey Horizon 3
SUNRISE MEDICAL (US) LLC · Model Horizon Size 3 · UDI-DI 05059804101036
10
510(k) clearances
3,241
Adverse events (13 deaths)
25
Recalls
189
Facilities
Description
The individually adjustable chest, hip and knee pads along with the footplates, provide unsurpassed levels of adjustability for proximal positioning - making the Horizon ideal for more complex users or adults who have not benefitted from standing therapy for some time. The Horizon range enables the safe and easy transfer of users using either mobile or tracking hoists, with the size 3 having been designed with the larger teen or adult client in mind- this has a maximum weight limit of 100kg (220lbs) as well as wider hip pad and chest lateral distances.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-19 | Ki Mobility Llc | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. |
| 2021-07-08 | Sunrise Medical (US) LLC | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| 2021-07-08 | Sunrise Medical (US) LLC | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. |
| 2021-06-21 | Accora Inc | The firm has identified a potential for the backrest to become detached from the chair. |
| 2019-03-28 | R82 A/S | Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat. |
| 2017-06-30 | R82 A/S | Replacement campaign on all units that have a gas spring head in aluminum. |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
| 2013-09-06 | Winco Mfg., LLC | A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.