Device recall

Z-2540-2019: Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights…

FDA device recall · Class II · Stryker Communications

Key facts

Recall number (Z-number) Z-2540-2019
Recall event 83355
Product Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for…
Product code FSY
Recalling firm Stryker Communications
Recall class Class II
Status Open, Classified
FEI number 3002975342

At a glance

  • None 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

Browse all FDA device recalls (products)