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U.S. Department of Health and Human Services

Class 2 Device Recall Omega Incline Platform Lift

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  Class 2 Device Recall Omega Incline Platform Lift see related information
Date Initiated by Firm April 12, 2017
Create Date April 26, 2017
Recall Status1 Terminated 3 on October 16, 2017
Recall Number Z-1880-2017
Recall Event ID 77053
Product Classification Transport, patient, powered - Product Code ILK
Product Omega Incline Platform Lift
Code Information s/n or lot number - Job Number 630046 through 630119
Recalling Firm/
Manufacturer
Savaria Concord Lifts, Inc.
2 Walker Dr
Brampton Canada
Manufacturer Reason
for Recall
Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift because bolts can come loose causing the carriage to separate from the trolley and the unit to fail
FDA Determined
Cause 2
Other
Action Savaria Concord Lifts Inc contacted the dealers to insure they received the parts and instructions and ask if they understand what is requested. If the dealers indicated they could no longer find the required parts new kits and instructions were sent on April 2015. Savaria Concord Lifts Inc contacted the dealers via e-mail and phone. For further questions, please call (800) 661-5112.
Quantity in Commerce 74
Distribution Worldwide Distribution - US Distribution and to North America.
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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