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Recall Observatory FDA recall evidence

Device product

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.

Z-0484-2014

February 19, 2013

Class II

Product summary

Firm
Trumpf Medical Systems, Inc.
Event
Event 66790
Status
Terminated
Classification
Class II
Quantity
287
Official record key
device-enforcement:Z-0484-2014

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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