Device recall

Z-2040-2017: RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a…

FDA device recall · Class II · Siemens Healthcare Diagnostics Inc

Key facts

Recall number (Z-number) Z-2040-2017
Recall event 76981
Product RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers…
Product code CHL
Recalling firm Siemens Healthcare Diagnostics Inc
Recall class Class II
Status Terminated
Termination date Aug 20, 2019
510(k) numbers K031560
FEI number 3002637618

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)