FDA Device recall 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 ligh…
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity ligh… by Trumpf Medical Systems, citing possible fatigue failure of the plastic joint may occur after an average use of seven years.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0484-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-19 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Trumpf Medical Systems |
| Distribution | AR, CA, CO, KS, MA, MI, MO, NC, NJ, NY, OH, OK, PA, SD, TX, WA |
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
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Identifiers
| code_info | Unknown |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems - Mobile Column TruSystem 7500, Material Number 1717023
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems - Operating Table TruSystem 7000 U, Material Number 1604788
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems
All Trumpf Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0484-2014%22
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