Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with
FDA device recall Z-0484-2014 · posted 2013-12-12 · Terminated
Recall details
- Recalling firm
- Trumpf Medical Systems, Inc.
- Reason for recall
- Possible fatigue failure of the plastic joint may occur after an average use of seven years.
- Action taken
- 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
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 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.
- Date initiated
- 2013-02-19
- Date posted
- 2013-12-12
- Date terminated
- 2017-03-06
- Location
- Charleston, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 (K011693) | Trumpf Medical Systems, Inc. | 2001-06-13 |