Z-2535-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- October 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 725 devices
Product Description
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
Reason for Recall
Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.
Distribution Pattern
Worldwide Distribution - US Distribution of the device was made nationwide. There was government distribution but no military distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Democratic People's Republic of Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Sweden, Thailand, Turkey, United Kingdom, and Viet Nam.
Code Information
UDI 04056719001698. 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