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DRIVEMEDICAL
Drive Devilbiss Healthcare · Model AK520ADA-AELR · UDI-DI 00822383136653
10
510(k) clearances
26,370
Adverse events (55 deaths)
40
Recalls
131
Facilities
Description
WenzeliteWheelchair Product Description: Cougar UltraLt,W/C,20"Det,TArm,1/cs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-24 | TiSport, Llc | Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if inv |
| 2018-09-11 | TiSport, Llc | The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. |
| 2016-07-01 | Sunrise Medical (US) LLC | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causin |
| 2016-01-27 | Karman Healthcare Inc | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets. |
| 2015-07-27 | Sunrise Medical (US) LLC | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. |
| 2015-07-27 | Sunrise Medical (US) LLC | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. |
| 2014-12-19 | Sunrise Medical (US) LLC | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| 2014-12-19 | Sunrise Medical (US) LLC | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| 2014-10-10 | Silver Star Brands | Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels.. |
| 2013-11-11 | Sunrise Medical (US) LLC | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. |
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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.