The Recall Desk
ModerateFDA (Devices)·Z-1658-2013·Announced 2013-07-10

Anspach Effort eMax 2 Plus Console Recalled for Low RPM

The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may run at lower than expected speeds in free-running mode.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The defect involves a performance deviation (lower RPM in free-running mode) that does not affect the loaded working range and has no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 61 units of the eMax 2 Plus Console, Single Port, with Irrigation (Reference SC2101). The recall is due to a defect where the RPM of the Motor Handpiece may be less than 80,000 RPM, potentially dropping to approximately 72,000 RPM, in the free-running state when using the optional Hand Control.

This condition occurs only when the Hand Control is fully depressed and there is no load on the cutting bur. The source text notes that this low RPM condition would not affect the power output of the Handpiece in the loaded working range, which is typically 50,000 to 70,000 RPM.

The affected units were distributed worldwide, including nationwide in the United States and in Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey. The agency classification for this recall is Class II.

The recalled product

Product
***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
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Dental Equipment
Hazard
Affected units
61

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • SC2100 System Console Emax 2 Plus
  • SC2101 System Console
  • Single Port with irrigation
  • SC2102 System Console
  • Single Port
  • without Irrigation

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 3 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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