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Recall Observatory FDA recall evidence

Device 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.

Z-1622-2013

April 26, 2013

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 65159
Status
Terminated
Classification
Class II
Quantity
13 Tables; 24 Extension devices
Official record key
device-enforcement:Z-1622-2013

Official wording

Reason: 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,

Code information: YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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,