Device recall

Z-0370-2019: GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma…

FDA device recall · Class I · GE Healthcare, LLC

Key facts

Recall number (Z-number) Z-0370-2019
Recall event 81339
Product GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Product code KPS
Recalling firm GE Healthcare, LLC
Recall class Class I
Status Terminated
Termination date Oct 8, 2020
510(k) numbers K962738
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)