MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position pati

FDA device recall Z-1622-2013 · posted 2013-07-01 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

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,

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LGX

Quantity affected

13 Tables; 24 Extension devices

Distribution

Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, German

Date initiated

2013-04-26

Date posted

2013-07-01

Date terminated

2014-04-29

Location

Wayne, NJ

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