Device recall

Z-0728-04: Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system…

FDA device recall · Class II · Eastman Kodak Co

Key facts

Recall number (Z-number) Z-0728-04
Recall event 28438
Product Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
Product code KPR
Recalling firm Eastman Kodak Co
Recall class Class II
Status Terminated
Termination date May 28, 2004
510(k) numbers K001341
FEI number 1315356

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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