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FDA Medical Device Recalls (openFDA)

Sunrise Medical Inc: Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727

Recall number
Z-0518-06
Recalling firm
Sunrise Medical Inc
Product
Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and distributed by Sunrise Medical, 2842 Business Park Ave., Fresno, CA 93727
Status
Terminated
Initiated
2005-11-15
Posted
2006-02-14
Terminated
2006-12-28
Reason
While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
Root cause
Other
Action
On November 9, 2005, the firm contacted its consignees via telephone, which was followed up by a mailing, to alert them of the situation. The firm is making arrangements to conduct the service correction at users'' residence. All appointmens are scheduled to be completed by December 15, 2005.
Quantity
5 units
Distribution
All 5 units were distributed to direct consignees, in CA, MA, NC, and OH.
Lot, serial or model codes
Serial numbers: 1GMo1B5500522 1GL02B7500022, 1GL02B7500019, 1GM01B6500422, 1GL02B9400338
510(k) numbers
K031289
PMA numbers
not on file
Product code
ITI
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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