| Class 2 Device Recall MAQUET YUNO OTN Mobile Operating Table and Extension Device | |
Date Initiated by Firm | April 26, 2013 |
Date Posted | July 01, 2013 |
Recall Status1 |
Terminated 3 on April 29, 2014 |
Recall Number | Z-1622-2013 |
Recall Event ID |
65159 |
510(K)Number | K033326 |
Product Classification |
Table, examination, medical, powered - Product Code LGX
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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 NJ 07470
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LGX
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