Device recall

Z-1101-2019: cone-beam CT system

FDA device recall · Class II · KaVo Dental Technologies LLC

Key facts

Recall number (Z-number) Z-1101-2019
Recall event 82045
Product cone-beam CT system
Product code OAS
Recalling firm KaVo Dental Technologies LLC
Recall class Class II
Status Open, Classified
510(k) numbers K170813, K180947
FEI number 1017522

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

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