Device recall

Z-0835-2011: Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard…

FDA device recall · Class III · AGFA Corp.

Key facts

Recall number (Z-number) Z-0835-2011
Recall event 57110
Product Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to apply hot keys from a keypad versus a keyboard.
Product code LLZ
Recalling firm AGFA Corp.
Recall class Class III
Status Terminated
Termination date Feb 1, 2011
510(k) numbers K081976
FEI number 3001236302

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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