Z-2290-2016 Class II Terminated

Recalled by Sunrise Medical (US) LLC — Fresno, CA

Recall Details

Product Type
Devices
Report Date
August 3, 2016
Initiation Date
July 1, 2016
Termination Date
September 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,142 devices in US, 1,710 devices internationally.

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.

Distribution Pattern

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,

Code Information

Model EIR 4 13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394. Serial number range: