The Recall Desk
HighFDA (Devices)·Z-0545-2014·Announced 2013-12-25

ASI Medical Recalls SEAC Advanced Dental Systems Due to Air Tank Rupture Risk

ASI Medical is recalling 337 SEAC Advanced Dental Systems because the miniature plastic air tank can potentially rupture.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential air tank rupture) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

ASI Medical, Inc. is initiating a field correction for 337 units of the SEAC Advanced Dental System, Model A591561. The recall is being conducted because the miniature plastic air tank included in the system can potentially rupture.

The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor, vacuum system, and water supply. It is designed to operate dental handpiece attachments and suction instruments and is intended for use in traditional dental office settings or mobile applications. The affected units are identified by Code No: 2010, 2020, 2120, and 2220, and Serial No: 590341-592066.

The affected products were distributed worldwide, including in the United States (nationwide), Austria, Aruba, Saudi Arabia, Canada, Germany, Spain, and the West Indies. Consumers and dental professionals should contact ASI Medical, Inc. for instructions on the field correction.

The recalled product

Product
SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced D
Manufacturer
ASI Medical, Inc.
Category
Medical Device — Dental Equipment
Hazard
Affected units
337

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 (3)

  • Code No: 2010
  • 2020
  • 2120 and 2220 Serial No: 590341- 592066

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · rupture

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