| Class 2 Device Recall Helion S Exam Light or H300 | |
Date Initiated by Firm | February 19, 2013 |
Date Posted | December 12, 2013 |
Recall Status1 |
Terminated 3 on March 06, 2017 |
Recall Number | Z-0484-2014 |
Recall Event ID |
66790 |
510(K)Number | K011693 |
Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
|
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. |
Code Information |
Unknown |
Recalling Firm/ Manufacturer |
Trumpf Medical Systems, Inc. 415 Jessen Ln Charleston SC 29492-7906
|
For Additional Information Contact | Lindsey Ronnenberg 888-474-9359 |
Manufacturer Reason for Recall | Possible fatigue failure of the plastic joint may occur after an average use of seven years. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = FSY
|
|
|
|