Trumpf Medical Systems, Inc.: 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.

Recall number

Z-0077-2013

Recalling firm

Trumpf Medical Systems, Inc.

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.

Status

Terminated

Initiated

2012-09-19

Posted

2012-10-18

Terminated

2014-01-21

Reason

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

Root cause

Device Design

Action

Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice.

Quantity

275 units

Distribution

Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.

Lot, serial or model codes

Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number).

510(k) numbers

["K011693"]

PMA numbers

not on file

Product code

FSY

Firm FEI

3003184737

Firm city

Charleston

Firm state

SC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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