ClearanceBrief
Recall Z-1622-2013 ยท LGX Table, Examination, Medical, Powered

Maquet Cardiovascular Us Sales, Llc

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.

DateJul 1, 2013 (initiated Apr 26, 2013)
StatusTerminated
ReasonMAQUET 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,
Root causeDevice Design
ActionMAQUET 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 instructe
Quantity13 Tables; 24 Extension devices
DistributionWorldwide 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 Afric
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033326PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
Philips Medical Systems, Inc., Oct 29, 2003