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.
FDA Recall Z-0484-2014 · Posted 2013-12-12
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Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeFSY
Date Initiated2013-02-19
Date Terminated2017-03-06
Product Quantity287
Reason for Recall
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Firm Action
TRUMPF sent an Urgent Recall Notice dated February 19, 2013, to all US affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
The recall notice instructed customers to verify if they still have these light systems, and if they do have the light system verify if they have a metal or plastic ring at the joint of concern (per the manufacturer's Safety Notice). TRUMPF will directly work with affected customers to replace the affected arm system.
For further questions please call ( 888 ) 474-9359.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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