CLASS II Device recall · Reported 18 Dec 2013 · FDA Enforcement Report
Helion S Exam Light or H300 The device is intended recalled
Trumpf Medical Systems is recalling Helion S Exam Light or H300 The device is intended to locally illuminate an examination, distributed in 16 states. The recall was initiated on 19 Feb 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0484-2014
- FDA event ID
- 66790
- Recalling firm
- Trumpf Medical Systems, Charleston, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Feb 2013
- FDA classified
- 12 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 19 Feb 2013 | Recall initiated by company | |
| 12 Dec 2013 | Classified by FDA | +296 days |
| 18 Dec 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
ArkansasCaliforniaColoradoKansasMassachusettsMichiganMissouriNorth CarolinaNew JerseyNew YorkOhioOklahomaPennsylvaniaSouth DakotaTexasWashington
Questions about this recall
Why was it recalled?
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Which lots are affected?
Unknown
Where was it sold?
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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