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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- ASI Medical, Inc.
- 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.
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