Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1880-2017Class II

Omega Incline Platform Lift

Savaria Concord Lifts, Inc. / initiated 2017-04-12 / Terminated

Savaria Concord Lifts, Inc. began a recall of Omega Incline Platform Lift on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1880-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Savaria Concord Lifts, Inc.
Product
Omega Incline Platform Lift
Product code
ILK Transport, Patient, Powered
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 root cause
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.
Product codes and lots
s/n or lot number - Job Number 630046 through 630119

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1880-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1880-2017Class IITerminatedVoluntary: Firm initiated