Device recall

Z-0388-2019: DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR…

FDA device recall · Class II · GE Healthcare Biosciences

Key facts

Recall number (Z-number) Z-0388-2019
Recall event 81454
Product DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and…
Product code REM
Recalling firm GE Healthcare Biosciences
Recall class Class II
Status Terminated
Termination date May 12, 2020
FEI number 1281317

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)