Device recall

Z-0780-2010: MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging…

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

Key facts

Recall number (Z-number) Z-0780-2010
Recall event 53989
Product MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications.
Product code LNH
Recalling firm Philips Medical Systems (Cleveland) Inc
Recall class Class II
Status Terminated
Termination date Sep 19, 2012
510(k) numbers K003853
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

Browse all FDA device recalls (products)