Device recall

Z-0934-2022: Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a…

FDA device recall · Class II · Deerfield Imaging, Inc.

Key facts

Recall number (Z-number) Z-0934-2022
Recall event 89713
Product Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.
Product code HBL
Recalling firm Deerfield Imaging, Inc.
Recall class Class II
Status Terminated
Termination date May 15, 2024
510(k) numbers K103493
FEI number 3010326005

At a glance

  • 1–9 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

Browse all FDA device recalls (products)