Device recall

Z-1179-2013: Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source…

FDA device recall · Class II · Chicago X-Ray Systems, Inc.

Key facts

Recall number (Z-number) Z-1179-2013
Recall event 65018
Product Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Product code EAP
Recalling firm Chicago X-Ray Systems, Inc.
Recall class Class II
Status Terminated
Termination date Sep 5, 2017
FEI number 1000115053

At a glance

  • None 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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