Breeze C Scooters 의 안전성 경고

Safety alert

2013-10-02

2013-10-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002b.html

Medical device safety alert: afikim breeze c scooters the united states food and drug administration (fda) has issued a medical device safety alert concerning breeze c scooters, manufactured by afikim electric vehicles. the affected products are identified as follows:- serial no.: 10390024, 11390060, 11490426, 12390107, 12490181, 10390025, 11390061, 11490433, 12390117, 12490182, 10390029, 11390069, 11490435, 12390120, 12490183, 10390030, 11390074, 11490445, 12490169, 12490184, 10390034, 11390095, 12390096, 12490170, 12490185, 10390037, 11390101, 12390097, 12490172, 12490186, 10490100, 11490111, 12390098, 12490173, 12490187, 10490108, 11490147, 12390099, 12490174, 12490188, 10490111, 11490176, 12390101, 12490175, 12490189, 10490113, 11490189, 12390102, 12490176, 12490190, 10490119, 11490277, 12390103, 12490177, 12490191, 10490121, 11490304, 12390104, 12490178, 12490192, 10490124, 11490305, 12390105, 12490179, 12490193, 11390058, 11490425, 12390106, 12490180 the products were manufactured from 02/07/2010 to 24/07/2012 and distributed from 15/09/2010 to 25/07//2013. during product testing, the manufacturer became aware of a potential scenario where an internal potentiometer wiper could become disconnected due to extensive wear. if this were to occur the device could continue to drive forward at a slow speed of approximately 2-4 mph and the only way to stop the device would be by turning off the main key switch. there is no injuries have been reported to date. the manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm370577.Htm http://www.Fda.Gov/safety/recalls/ucm370503.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.