Device recall

Z-0531-2021: BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used…

FDA device recall · Class II · Verathon, Inc.

Key facts

Recall number (Z-number) Z-0531-2021
Recall event 86528
Product BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Product code ITX
Recalling firm Verathon, Inc.
Recall class Class II
Status Terminated
Termination date Jun 29, 2022
510(k) numbers K172356
FEI number 3022472

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

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