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U.S. Department of Health and Human Services

Class 2 Device Recall MAQUET YUNO OTN Mobile Operating Table and Extension Device

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 Class 2 Recall
MAQUET YUNO OTN Mobile Operating Table and Extension Device
see related information
Date Posted July 01, 2013
Recall Status1 Terminated on April 29, 2014
Recall Number Z-1622-2013
Recall Event ID 65159
Premarket Notification
510(K) Number
K033326 
Product Classification Table, Examination, Medical, Powered - Product Code LGX
Product MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.
Code Information YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
Recalling Firm/
Manufacturer
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne, New Jersey 07470
For Additional Information Contact Mr. Mark Dinger
973-709-7691
Manufacturer 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,
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 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, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LGX and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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