Device recall

Z-1601-2024: ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select…

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

Key facts

Recall number (Z-number) Z-1601-2024
Recall event 94211
Product ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Product code IYN
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K232617
FEI number 3023245

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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)