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.
FDA Recall Z-2290-2016 · Posted 2016-07-25
Recalling FirmSunrise Medical (US) LLC
Recall StatusTerminated
Product CodeIOR
Date Initiated2016-07-01
Date Terminated2017-09-11
Product Quantity12,142 devices in US, 1,710 devices internationally.
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.
Firm 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.
Root Cause
Device Design
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.