Trumpf Medical Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0077-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 19, 2012

Date Posted: October 24, 2012

Recall Number: Z-0077-2013

Event ID: 63255

Reason for Recall:

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

Status: Terminated

Product Quantity: 275 units

Code Information:

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).

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated