Device recall

Z-0917-2022: MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part…

FDA device recall · Class III · Volcano Corp

Key facts

Recall number (Z-number) Z-0917-2022
Recall event 89698
Product MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Product code DSA
Recalling firm Volcano Corp
Recall class Class III
Status Open, Classified
FEI number 3008363989

At a glance

  • None 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)