Device recall

Z-0205-2020: Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material…

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

Key facts

Recall number (Z-number) Z-0205-2020
Recall event 83655
Product Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Product code JJE
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Terminated
Termination date May 5, 2022
510(k) numbers K151792
FEI number 2432235

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)