Recall Z-0484-2014— Trumpf Medical Systems, Inc.

Name: FDA recall Z-0484-2014
Creator: U.S. Food and Drug Administration
Published: 2013-02-19

Class II · Terminated

Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2013-02-19, terminated 2017-03-06. It names one FDA 510(k) clearance: K011693. Product: Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.. Reason: Possible fatigue failure of the plastic joint may occur after an average use of seven years..

Recalling firm: Trumpf Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-19
Terminated: 2017-03-06
Firm location: Charleston, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K011693 — TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001Trumpf Medical Systems, Inc.·cleared 2001-06-13

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

Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.

Reason for recall

Possible fatigue failure of the plastic joint may occur after an average use of seven years.

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