Trumpf Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0484-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: February 19, 2013
Date Posted: December 18, 2013
Recall Number: Z-0484-2014
Event ID: 66790
Reason for Recall:

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

Status: Terminated
Product Quantity: 287
Code Information:

Unknown

Distribution Pattern:

US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.

Voluntary or Mandated:

Voluntary: Firm initiated