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Leckey MyGo Stander

SUNRISE MEDICAL (US) LLC · Model MyGo Stander · UDI-DI 05059804143005

INM
10
510(k) clearances
4,800
Adverse events (13 deaths)
25
Recalls
189
Facilities

Description

The Leckey MyGo Stander delivers truly excellent prone, supine and upright positioning for children with moderate to complex needs.

Recalls

DateFirmReason
2021-11-19Ki Mobility LlcThe Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
2021-07-08Sunrise Medical (US) LLCThe seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-07-08Sunrise Medical (US) LLCThe seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-06-21Accora IncThe firm has identified a potential for the backrest to become detached from the chair.
2019-03-28R82 A/SFirm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
2017-06-30R82 A/SReplacement campaign on all units that have a gas spring head in aluminum.
2013-09-06Winco Mfg., LLCA 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
2013-09-06Winco Mfg., LLCA 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
2013-09-06Winco Mfg., LLCA 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
2013-09-06Winco Mfg., LLCA 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.