|
Catalog Number 83171 |
Device Problems
Mechanical Problem (1384); Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/03/2021 |
Event Type
malfunction
|
Event Description
|
It was reported the blue domes in ors 9, 6, and 2 have fallen off and the back of the light electronics are showing.There were no reported injuries or adverse consequences.
|
|
Manufacturer Narrative
|
It was reported that the blue dome separated from an f generation light.The light head reported is within the scope of (b)(4) and will be handled accordingly.There was no reported patient involvement, no injuries, no adverse consequences or delay.Per (b)(4) revision p, the severity is s0.
|
|
Manufacturer Narrative
|
[supplemental 001] fields h6 for device code grid and conclusion code grid were updated.
|
|
Event Description
|
It was reported the blue domes in ors 9, 6, and 2 have fallen off and the back of the light electronics are showing.There were no reported injuries or adverse consequences.
|
|
Search Alerts/Recalls
|
|
|