Helion S Exam Light or H300 The device is intended to locally… — Class II medical device recall Z-0484-2014
Terminated recall by Trumpf Medical Systems, Inc., reported 2013-12-18, distributed in AR, CA, CO, KS, MA, MI, MO, NC…. Possible fatigue failure of the plastic joint may occur after an average use of seven years.
| Recall number | Z-0484-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trumpf Medical Systems, Inc., Charleston, SC, United States |
| Recall initiated | 2013-02-19 |
| Classified | 2013-12-12 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2017-03-06 |
| Distributed | AR, CA, CO, KS, MA, MI, MO, NC, NJ, NY, OH, OK, PA, SD, TX, WA |
| Quantity | 287 |
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.
Reason for recall
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0484-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.