Device recall

Z-0690-2008: GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare…

FDA device recall · Class II · GE Healthcare

Key facts

Recall number (Z-number) Z-0690-2008
Recall event 45845
Product GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
Product code MQB
Recalling firm GE Healthcare
Recall class Class II
Status Terminated
Termination date Jan 29, 2016
510(k) numbers K050489
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

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