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FDA Medical Device Recalls (openFDA)

Sunrise Medical Inc: Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.

Recall number
Z-0831-2011
Recalling firm
Sunrise Medical Inc
Product
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
Status
Terminated
Initiated
2009-02-02
Posted
2010-12-28
Terminated
2011-01-03
Reason
The stabilizer bar was inadvertently omitted during the manufacturing process.
Root cause
Process change control
Action
An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.
Quantity
23
Distribution
Worldwide Distribution -- United States and Canada.
Lot, serial or model codes
Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.
510(k) numbers
["K973673"]
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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