Device recall

Z-0199-2019: Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a…

FDA device recall · Class II · Canon Medical System, USA, INC.

Key facts

Recall number (Z-number) Z-0199-2019
Recall event 81026
Product Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
Product code LNH
Recalling firm Canon Medical System, USA, INC.
Recall class Class II
Status Open, Classified
510(k) numbers K120638
FEI number 2020563

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)