Device recall

Z-0503-2021: Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with…

FDA device recall · Class II · Olympus Corporation of the Americas

Key facts

Recall number (Z-number) Z-0503-2021
Recall event 86649
Product Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the…
Product code FDS
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Terminated
Termination date Jun 7, 2022
510(k) numbers K971660
FEI number 2429304

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)