FDAFDA · Food and drugs·Recall number Z-1658-2013
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** 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.
Published July 10, 2013 · Recall initiated: June 24, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The RPM of the Motor Handpiece may be less than 80,000 RPM.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- 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;
- Lot
- SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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