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U.S. Department of Health and Human Services

Class 2 Device Recall Savaria Stairfriend

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  Class 2 Device Recall Savaria Stairfriend see related information
Date Initiated by Firm April 12, 2017
Create Date April 27, 2017
Recall Status1 Terminated 3 on October 16, 2017
Recall Number Z-1882-2017
Recall Event ID 77042
Product Classification Transport, patient, powered - Product Code ILK
Product The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
Code Information s/n or lot number - 690009 thru 690235
Recalling Firm/
Manufacturer		 Savaria Concord Lifts, Inc.
2 Walker Dr
Brampton Canada
Manufacturer Reason
for Recall		 Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm plans to notify its customers thru the phone and also via the dealers it sells it product too.
Quantity in Commerce 226
Distribution North America / South America, please see attached list.
Total Product Life Cycle TPLC 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.
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