Device recall

Z-2894-2018: Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital…

FDA device recall · Class II · Philips Electronics North America Corporation

Key facts

Recall number (Z-number) Z-2894-2018
Recall event 80645
Product Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple…
Product code MHX
Recalling firm Philips Electronics North America Corporation
Recall class Class II
Status Open, Classified
510(k) numbers K163649
FEI number 1218950

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)