Device recall

Z-2256-2016: ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704)…

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

Key facts

Recall number (Z-number) Z-2256-2016
Recall event 74309
Product ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests…
Product code JLW
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Terminated
Termination date Jun 7, 2018
510(k) numbers K141999
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)