Device recall

Z-0910-06: Magnetic Resonance Imaging Device

FDA device recall · Class II · Hitachi Medical Systems America Inc

Key facts

Recall number (Z-number) Z-0910-06
Recall event 35087
Product Magnetic Resonance Imaging Device
Product code LNH
Recalling firm Hitachi Medical Systems America Inc
Recall class Class II
Status Terminated
Termination date Feb 16, 2012
510(k) numbers K002420, K022390, K032232, K974212
FEI number 1528028

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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