Device recall

Z-0012-2014: GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended…

FDA device recall · Class II · GE Healthcare, LLC

Key facts

Recall number (Z-number) Z-0012-2014
Recall event 66277
Product GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and…
Product code JAA
Recalling firm GE Healthcare, LLC
Recall class Class II
Status Terminated
Termination date May 22, 2014
510(k) numbers K011624, K081091, K760466, K801320, K973039
FEI number 2126677

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)