FDA Recall Terminated

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.

Recall: Z-2290-2016 · Initiated July 1, 2016

Recall

Recall Number
Z-2290-2016
Event Number
74596
Firm
Sunrise Medical (US) LLC
FEI Number
2937137
Product Code
IOR
Status
Terminated
Root Cause
Device Design
Initiated
July 1, 2016
Posted
July 25, 2016
Terminated
September 11, 2017
Address
2842 N Business Park Ave, Fresno, CA, 93727-1328

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

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.

Action

The firm began calling dealers to alert them to the recall and obtain primary contacts information. Dealers were then sent their list of Quickie Q7 wheelchairs that records show being sold by them and dealers are asked to return a list of chairs they are able to locate for correction. The first dealer letter was sent via e-mail on July 7, 2016.

Distribution

US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands,

Quantity

12,142 devices in US, 1,710 devices internationally.