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Leckey Pronestander

SUNRISE MEDICAL (US) LLC · Model Pronestander · UDI-DI 05059804300002

INM

510(k) clearances

3,241

Adverse events (13 deaths)

Recalls

189

Facilities

Description

The Leckey Pronestander is a robust stander with a choice of five prone positions from 45° to 85°. In addition to the prone angle adjustment, the stander covers a large growth range and has adjustable chest, hip and knee supports, to ensure that it meets a large range of clinical needs.

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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Data 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.