Recall Z-2535-2018 ยท JAI Couch, Radiation Therapy, Powered
Elekta, Inc.
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
| Date | May 16, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 725 devices |
| Distribution | 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 Republ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072898 | HEXAPOD EVO RT COUCH TOP Medical Intelligence Medizintechnik GmbH, Oct 25, 2007 |