Recall Z-2290-2016— Sunrise Medical (US) LLC

Name: FDA recall Z-2290-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-01

Class II · Terminated

Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2016-07-01, terminated 2017-09-11. It names one FDA 510(k) clearance: K123975. Product: Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.. Reason: 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..

Recalling firm: Sunrise Medical (US) LLC
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Terminated: 2017-09-11
Firm location: Fresno, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123975 — QUICKIE & ZIPPIE SERIESSunrise Medical·cleared 2013-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.