RecallDepth

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.

Company
Sunrise Medical (Us) Llc
Recall Initiated
July 1, 2016
Posted
July 25, 2016
Terminated
September 11, 2017
Recall Number
Z-2290-2016
Quantity
12,142 devices in US, 1,710 devices internationally.
Firm Location
Fresno, CA

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

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,

Lot / Code Info

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:

Root Cause

Device Design

Action Taken

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.

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