Device recall

Z-0260-2010: GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6…

FDA device recall · Class II · Philips Medical Systems (Cleveland) Inc

Key facts

Recall number (Z-number) Z-0260-2010
Recall event 53517
Product GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.
Product code JAK
Recalling firm Philips Medical Systems (Cleveland) Inc
Recall class Class II
Status Terminated
Termination date Nov 24, 2009
510(k) numbers K051170
FEI number 1525965

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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