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U.S. Department of Health and Human Services

Class 2 Device Recall Permobil Chairman 2K powered wheelchair, Model 1280

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 Class 2 Device Recall Permobil Chairman 2K powered wheelchair, Model 1280see related information
Date Initiated by FirmJanuary 01, 2003
Date PostedMarch 21, 2003
Recall Status1 Terminated 3 on June 25, 2008
Recall NumberZ-0671-03
Recall Event ID 25692
510(K)NumberK991658 
Product Classification unknown device name - Product Code I--TI
ProductPermobil Chairman 2K powered wheelchair, Model 1280
Code Information Serial Numbers: 1100068 to 1103702
Recalling Firm/
Manufacturer		 Permobile Inc.
6961 Eastgate Blvd
Lebanon TN 370906005
For Additional Information ContactBarry Steelman
800-736-0925
Manufacturer Reason
for Recall		Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
FDA Determined
Cause 2		Other
ActionPermobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold.
Quantity in Commerce1582
DistributionNationwide, Puerto Rico, Canada
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 = I--TI
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