Device product
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
Z-1208-2023
Product summary
- Event
- Event 91601
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3896 units
- Official record key
device-enforcement:Z-1208-2023
Official wording
Reason: Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Code information: UDI-DI: +ESANS100010 All Serial Numbers
Distribution pattern: Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
Derived failure modes
-
Unknown
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button