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FDA Medical Device Recalls (openFDA)

Sunrise Medical (US) LLC: 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.

Recall number
Z-2290-2016
Recalling firm
Sunrise Medical (US) LLC
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.
Status
Terminated
Initiated
2016-07-01
Posted
2016-07-25
Terminated
2017-09-11
Reason
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
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
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,
Lot, serial or model codes
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:
510(k) numbers
["K123975"]
PMA numbers
not on file
Product code
IOR
Firm FEI
2937137
Firm city
Fresno
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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