Device recall

Z-0545-2014: SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a…

FDA device recall · Class II · ASI Medical, Inc.

Key facts

Recall number (Z-number) Z-0545-2014
Recall event 66983
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…
Product code EIA
Recalling firm ASI Medical, Inc.
Recall class Class II
Status Terminated
Termination date Aug 11, 2014
510(k) numbers K974487
FEI number 1000160293

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)