Device recall

Z-2654-2017: SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

FDA device recall · Class II · Shimadzu Medical Systems Usa Com

Key facts

Recall number (Z-number) Z-2654-2017
Recall event 77351
Product SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Product code KPR
Recalling firm Shimadzu Medical Systems Usa Com
Recall class Class II
Status Terminated
Termination date Oct 1, 2019
510(k) numbers K152244
FEI number 1000125362

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)