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U.S. Department of Health and Human Services

Class 2 Device Recall DeltaVision OMX SR Imaging System

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  Class 2 Device Recall DeltaVision OMX SR Imaging System see related information
Date Initiated by Firm September 10, 2018
Create Date November 20, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-0388-2019
Recall Event ID 81454
Product Classification Spectroscopy instrument - Product Code REM
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 localization microscopy may be used to examine a variety of samples over long periods of time.
Code Information System Serial number OM20072 - OM40122
Recalling Firm/
Manufacturer		 GE Healthcare Biosciences
14 Walkup Dr
Westborough MA 01581-1019
For Additional Information Contact
508-475-2000
Manufacturer Reason
for Recall		 Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
FDA Determined
Cause 2		 Device Design
Action The firm, GE Healthcare, sent an "Important Electronic Product Radiation Warning" letter to affected customers on September 10, 2018. The letter identified the affected product, problem and actions to be taken. GE Healthcare will, without charge, remedy the defect or bring the product into compliance. Your GE Service Representative will contact you to implement the correction. For questions contact your local GEHC service representative or call 425-657-1512 or email: trisha.koenke@ge.com.
Quantity in Commerce 39
Distribution Worldwide - US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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