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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 07, 2003
Date PostedMay 15, 2003
Recall Status1 Terminated 3 on June 25, 2008
Recall NumberZ-0834-03
Recall Event ID 25733
510(K)NumberK991658 
Product Classification Wheelchair, Powered - Product Code ITI
ProductPermobil Chairman 2K powered wheelchair
Code Information Serial numbers: 1100155 to 1102472 and 4100019 through 4100225.
Recalling Firm/
Manufacturer		 Permobile Inc.
6961 Eastgate Blvd
Lebanon TN 370906005
For Additional Information ContactBarry Steelman
800-736-0925 Ext. 256
Manufacturer Reason
for Recall		One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
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. This list also includes the name of the individual for whom the wheelchair was specified at the time of order from Permobil Inc, where applicable. The Permobil field representatives have been trained to perform the upgrade and have been provided the necessary tools to complete the task. They will also train and supervise the Dealer''s technicians who will effect the upgrade at the Dealer level, as the field representatives will rely upon their Dealer network to complete the upgrades in a timely fashion.
Quantity in Commerce1,319
DistributionNationwide, Canada and Puerto Rico
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 = ITI
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