Device recall

Z-0918-2017: Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire…

FDA device recall · Class II · Shimadzu Medical Systems

Key facts

Recall number (Z-number) Z-0918-2017
Recall event 75834
Product Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Product code IZO
Recalling firm Shimadzu Medical Systems
Recall class Class II
Status Terminated
Termination date Dec 11, 2017
FEI number 1000125362

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)