Sunrise Medical Tecnologias, S.A. de CV

7 recall(s) on record — most severe on record: Class II.

Devices registered here (1)

• Wheelchair, Powered
  Product code ITI · Class II · Physical Medicine · 21 CFR 890.3860

Recalls & enforcement

• Class IITerminated2021-07-08
  The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
• Class IITerminated2020-02-13
  Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.
• Class IITerminated2016-07-01
  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 causing the backrest to detach from the chair frame.
• Class IITerminated2015-07-27
  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.
• Class IITerminated2014-12-19
  There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
• Class IITerminated2013-11-11
  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. And when not using the positioning strap, there is a risk that the occupant could slide out of the s
• Class IITerminated2012-06-26
  Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.

Related

• All facilities operated by Sunrise Medical (US) LLC
• SUNRISE MEDICAL (US) LLC (CA)
• Sunrise Medical (US) LLC (TN)
• James Leckey Design Ltd (GB)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →