Recall Z-0545-2014 ยท EIA Unit, Operative Dental
ASI Medical, Inc.
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 mou
| Date | Dec 19, 2013 (initiated Nov 5, 2013) |
| Status | Terminated |
| Reason | ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture. |
| 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 r |
| Quantity | 337 |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 Asi Medical, Inc., Feb 18, 1998 |