FDAFDA · Food and drugs·Recall number Z-0484-2014
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.
Published December 18, 2013 · Recall initiated: February 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trumpf Medical Systems, Inc.
- Distributor
- US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
- Lot
- Unknown
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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