Terminated

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

FDA Recall Z-2535-2018 · Posted None

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeJAI

Date Initiated2018-05-16

Date Terminated2020-10-30

Product Quantity725 devices

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.

Firm Action

The letter from Elekta dated May 2018 was issued via email 5/16/2018 and was flagged "URGENT IMPORTANT FIELD SAFETY NOTIFICATION. The letter identified the affected product, problem and actions to be taken.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072898HEXAPOD EVO RT COUCH TOPMedical Intelligence Medizintechnik GmbH · 2007-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.