Date Initiated by Firm |
January 13, 2012 |
Date Posted |
February 24, 2012 |
Recall Status1 |
Terminated 3 on February 27, 2012 |
Recall Number |
Z-1103-2012 |
Recall Event ID |
61082 |
510(K)Number |
K973673
|
Product Classification |
Wheelchair, mechanical - Product Code IOR
|
Product |
Sunrise Medical Zippie TS wheelchair
To empower physically challenged person by providing a means or mobility. |
Code Information |
Model number: E1Z1A; Serial number: Z1SE-006474. |
Recalling Firm/ Manufacturer |
Sunrise Medical (US) LLC 2842 N Business Park Ave Fresno CA 93727-1328
|
For Additional Information Contact |
Laurie H. Roberts, RAC 559-294-2572
|
Manufacturer Reason for Recall |
One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.
|
FDA Determined Cause 2 |
Employee error |
Action |
Sunrise Medical contacted customer by telephone on January 17, 2012 to arrange for removal of transit brackets. The Sunrise Sales rep then visited the customers on January 18, 2012 and removed the bracket from the chair making it appropriate for intended use.
If you need any additional information or have any questions, call 559-348-2572 or email: laurie.roberts@sunmed.com. |
Quantity in Commerce |
1 chair |
Distribution |
Nationwide distribution: OK only. |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = IOR and Original Applicant = SUNRISE MEDICAL, INC.
|