MAQUET YUNO OTN Mobile Operating Table and Extension Device 의 리콜

Recall

65159

Class 2

Z-1622-2013

2013-04-26

2013-07-01

Terminated

United States

2014-04-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118049

Maquet has identified a potential issue with the extension device handle (part number 1433.62a1) and will make enhancements to the yuno table (part number 1433.01f0). identification of the extension device issue: by fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. when the lever is released,.

MAQUET Getinge Group issued an Urgent Medical Device Recall letter/"Field Action Response Form dated April 26, 2013, via Federal Express to all affected customers. The recall notification identifies the product, issue with the product, and measures to be taken by the user. Customers were instructed that the firm would contact them to arrange for a loaner YUNO table and extension device while the table and extension device are upgraded. Upon completion of the upgrades, MAQUET would reinstall their upgraded YUNO table and extension device and remove the loaner device. Customers were instructed to complete and return the enclosed Field Action Response Form, acknowledging their receipt and understanding of the communication by e-mailing a scanned copy to FieldAction@maquet.com or via fax at 973-807-1658. Customers with questions were instructed to contact their MAQUET representative or MAQUET Technical Support at 888-627-8383, option 3, followed by option 1. For questions regarding this recall call 973-709-7691.