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.
Enforcement
- Recall Number
- Z-1622-2013
- Event ID
- 65159
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Cardiovascular Us Sales, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 10, 2013
- Initiation Date
- April 26, 2013
- Classification Date
- July 1, 2013
- Termination Date
- April 29, 2014
- Address
- 45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States
Description
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.
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,
YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
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.
13 Tables; 24 Extension devices