SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system wi
FDA device recall Z-0545-2014 · posted 2013-12-19 · Terminated
Recall details
- Recalling firm
- ASI Medical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- EIA
- Quantity affected
- 337
- Distribution
- Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.
- Date initiated
- 2013-11-05
- Date posted
- 2013-12-19
- Date terminated
- 2014-08-11
- Location
- Centennial, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 (K974487) | Asi Medical, Inc. | 1998-02-18 |