Recall Z-1514-2014— Elekta, Inc.

Name: FDA recall Z-1514-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-04-17, terminated 2015-01-29. It names one FDA 510(k) clearance: K072898. Product: HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.. Reason: If screws are not properly tightened with a torque wrench they may become loose over time..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-17
Terminated: 2015-01-29
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 Couchtop. To support and aid in positioning a patient during radiation therapy.

Reason for recall

If screws are not properly tightened with a torque wrench they may become loose over time.

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