Device product
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Z-0395-2022
Product summary
- Event
- Event 88906
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52 boxes (5 units/box)
- Official record key
device-enforcement:Z-0395-2022
Official wording
Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Code information: Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
Derived failure modes
-
Unknown
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.