Device 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.
Z-0484-2014
Product summary
- Event
- Event 66790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 287
- Official record key
device-enforcement:Z-0484-2014
Official wording
Reason: Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Code information: Unknown
Distribution pattern: US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Derived failure modes
-
Unknown
Possible fatigue failure of the plastic joint may occur after an average use of seven years.