Device recall

Z-0904-2011: VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany…

FDA device recall · Class II · Carl Zeiss Meditec Inc

Key facts

Recall number (Z-number) Z-0904-2011
Recall event 52716
Product VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. Product Quantity Distributed (Int) 2540 units
Product code EPT
Recalling firm Carl Zeiss Meditec Inc
Recall class Class II
Status Terminated
Termination date Feb 9, 2011
FEI number 2918630

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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