Device recall

Z-1971-2023: Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G…

FDA device recall · Class II · Ellex Medical Pty Ltd.

Key facts

Recall number (Z-number) Z-1971-2023
Recall event 92532
Product Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Product code HQF
Recalling firm Ellex Medical Pty Ltd.
Recall class Class II
Status Open, Classified
510(k) numbers K081565, K142398
FEI number 3002806902

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)