Device product
***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
Z-1657-2013
Product summary
- Event
- Event 64973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-1657-2013
Official wording
Reason: The RPM of the Motor Handpiece may be less than 80,000 RPM.
Code information: SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation.
Distribution pattern: Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
Derived failure modes
-
Unknown
The RPM of the Motor Handpiece may be less than 80,000 RPM.