Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2290-2016Class II

Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to...

Sunrise Medical, Inc. / initiated 2016-07-01 / Terminated / root cause: design

Sunrise Medical (US) LLC began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2290-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
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.
Product code
IOR Wheelchair, Mechanical
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.
Root cause tag
design
FDA root cause
Device Design
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.
Quantity in commerce
12,142 devices in US, 1,710 devices internationally.
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,
Product codes and lots
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:

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2290-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2290-2016Class IITerminatedVoluntary: Firm initiated