FDA Enforcement
Class II
Terminated
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: Z-0484-2014
·
Reported December 18, 2013
Enforcement
- Recall Number
- Z-0484-2014
- Event ID
- 66790
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Trumpf Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2013
- Initiation Date
- February 19, 2013
- Classification Date
- December 12, 2013
- Termination Date
- March 6, 2017
- Address
- 415 Jessen Ln, Charleston, SC, 29492-7906, United States
Description
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.
Code Info
Unknown
Distribution
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Quantity
287