Z-0545-2014Class II

SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental...

Name: Z-0545-2014 SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental...
Creator: ASI Medical, Inc.
Published: 2013-11-05
License: https://open.fda.gov/license/

ASI Medical, Inc. / initiated 2013-11-05 / Terminated / root cause: design

FDA source

ASI Medical, Inc. began a recall of 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... on 2013-11-05. FDA classified it as Class II and gives the reason as "ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0545-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-05
Posted: 2013-12-19
Terminated: 2014-08-11
Recalling firm: ASI Medical, Inc.
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 Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
Product code: EIA Unit, Operative Dental
Reason for recall: ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
Root cause tag: design
FDA root cause: Device Design
Action: ASI Medical sent an Field Correction Action and Safety Notice letter dated November 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. REQUIRED FIELD CORRECTION Our field correction will consist of sending you a warning label to be applied to the back service access panel of the cart and an ASME safety pop off valve that will open and exhaust if pressure should reach over 100 psi. This safety pop off valve is designed be easily installed in line between the air compressor and air tank in your system. We are requesting your cooperation in making this field correction.
Quantity in commerce: 337
Distribution: Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.
Product codes and lots: Code No: 2010, 2020,2120 and 2220 Serial No: 590341- 592066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0545-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0545-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

Product code EIA

K974487Class ISeac Advanced Dental System - Model 2001,2010 or Model 2020Asi Medical, Inc. / cleared 1998-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)