Device recall

Z-1645-2023: EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product…

FDA device recall · Class II · Philips North America Llc

Key facts

Recall number (Z-number) Z-1645-2023
Recall event 92063
Product EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Product code DSJ
Recalling firm Philips North America Llc
Recall class Class II
Status Open, Classified
510(k) numbers K190624
FEI number 3016618143

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)