Recall Z-2535-2018— Elekta, Inc.

Name: FDA recall Z-2535-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-16

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2018-05-16, terminated 2020-10-30. It names one FDA 510(k) clearance: K072898. Product: 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: 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Terminated: 2020-10-30
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K072898 — HEXAPOD EVO RT COUCH TOPMedical Intelligence Medizintechnik GmbH·cleared 2007-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.