Device recall

Z-0818-2012: EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical…

FDA device recall · Class II · Pentax Medical Company

Key facts

Recall number (Z-number) Z-0818-2012
Recall event 60788
Product EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract.
Product code EOQ
Recalling firm Pentax Medical Company
Recall class Class II
Status Terminated
Termination date Nov 27, 2012
510(k) numbers K023376
FEI number 1000080301

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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