Recall record at a glance
| Official record | Z-0545-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ASI Medical, Inc. |
| Report date | Dec 25, 2013 |
| Recall initiation date | Nov 5, 2013 |
| Quantity | 337 |
| Location | Centennial, CO, United States |
Official product description
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.
Why the product was recalled
ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
Distribution information
Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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