Device recall

Z-0765-2024: Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3…

FDA device recall · Class II · Getinge Usa Sales Inc

Key facts

Recall number (Z-number) Z-0765-2024
Recall event 93567
Product Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Product code FSY
Recalling firm Getinge Usa Sales Inc
Recall class Class II
Status Open, Classified
FEI number 3013876692

At a glance

  • None Linked 510(k)s
  • 10–99 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)