Device recall

Z-0712-06: ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.)…

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

Key facts

Recall number (Z-number) Z-0712-06
Recall event 35001
Product ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America)
Product code KPS
Recalling firm Siemens Medical Solutions USA Inc
Recall class Class II
Status Terminated
Termination date Dec 22, 2009
510(k) numbers K003241, K940478
FEI number 1034973

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

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