Device recall

Z-0090-2021: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F

FDA device recall · Class II · Siemens Medical Solutions USA, Inc.

Key facts

Recall number (Z-number) Z-0090-2021
Recall event 85807
Product ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Product code OBJ
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Terminated
Termination date Oct 15, 2021
510(k) numbers K173618
FEI number 3023245

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

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