FDA Medical Device Recalls (openFDA)
Trumpf Medical Systems, Inc.: 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.
- Recall number
- Z-0484-2014
- Recalling firm
- Trumpf Medical Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-02-19
- Posted
- 2013-12-12
- Terminated
- 2017-03-06
- Reason
- Possible fatigue failure of the plastic joint may occur after an average use of seven years.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 287
- Distribution
- US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
- Lot, serial or model codes
- Unknown
- 510(k) numbers
- ["K011693"]
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 3003184737
- Firm city
- Charleston
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28