Device recall

Z-0491-2014: Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream…

FDA device recall · Class II · Carestream Health Inc.

Key facts

Recall number (Z-number) Z-0491-2014
Recall event 66744
Product Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are…
Product code IZL
Recalling firm Carestream Health Inc.
Recall class Class II
Status Terminated
Termination date Nov 18, 2015
FEI number 1315356

At a glance

  • None 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)