The Recall Desk
ModerateFDA (Devices)·Z-1657-2013·Announced 2013-07-10

Anspach Effort eMax 2 Plus Console Recalled for Low Motor RPM

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

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, and the defect involves a performance deviation (lower RPM in free-running state) that does not affect the loaded working range or result in reported injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 61 units of the eMax 2 Plus dental console (Reference SC2100) due to a performance defect. The recall involves specific system consoles, including the SC2100, SC2101, and SC2102 models.

The defect involves the Motor Handpiece potentially operating at less than 80,000 RPM (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 issue does not affect the power output of the handpiece in the loaded working range, which typically operates between 50,000 and 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. Users should contact the recalling firm for further instructions regarding the recall.

The recalled product

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
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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