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U.S. Department of Health and Human Services

Class 2 Device Recall Quickie Q7 wheelchair. Model EIR4

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 Class 2 Device Recall Quickie Q7 wheelchair. Model EIR4see related information
Date Initiated by FirmJuly 01, 2016
Date PostedJuly 25, 2016
Recall Status1 Terminated 3 on September 11, 2017
Recall NumberZ-2290-2016
Recall Event ID 74596
510(K)NumberK123975 
Product Classification Wheelchair, mechanical - Product Code IOR
ProductQuickie 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.
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:
FEI Number 2937137
Recalling Firm/
Manufacturer		 Sunrise Medical (US) LLC
2842 N Business Park Ave
Fresno CA 93727-1328
For Additional Information ContactLaurie H.Roberts
559-348-2572
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe 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 Commerce12,142 devices in US, 1,710 devices internationally.
DistributionUS 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,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = IOR
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