Recall Z-0077-2013— Trumpf Medical Systems, Inc.

Name: FDA recall Z-0077-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-19

Class II · Terminated

Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2012-09-19, terminated 2014-01-21. It names one FDA 510(k) clearance: K011693. Product: Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.. Reason: Incidents regarding fractures of the front joint of the spring arm have been reported..

Recalling firm: Trumpf Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-19
Terminated: 2014-01-21
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 and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

Reason for recall

Incidents regarding fractures of the front joint of the spring arm have been reported.

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