Device recall

Z-0543-2009: Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI…

FDA device recall · Class II · Siemens Medical Solutions, USA, Inc

Key facts

Recall number (Z-number) Z-0543-2009
Recall event 49457
Product Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
Product code LLZ
Recalling firm Siemens Medical Solutions, USA, Inc
Recall class Class II
Status Terminated
Termination date Oct 18, 2010
510(k) numbers K040896
FEI number 3003304172

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)