Device recall

Z-0449-2022: Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated…

FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.

Key facts

Recall number (Z-number) Z-0449-2022
Recall event 89160
Product Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
Product code JGS
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K151767
FEI number 2432235

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)