Recall Z-0563-2016— Trumpf Medical Systems, Inc.

Name: FDA recall Z-0563-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-02

Class II · Completed

Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2015-11-02. It names 2 FDA 510(k) clearances: K102758, K061317. Product: Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5. Reason: The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall..

Recalling firm: Trumpf Medical Systems, Inc.
Classification: Class II
Status: Completed
Initiated: 2015-11-02
Firm location: Charleston, SC, United States

510(k) clearances named in this recall

2 on FDA's record

K102758 — TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg·cleared 2010-10-26
K061317 — ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg·cleared 2006-06-22

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

Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

Reason for recall

The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.

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