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U.S. Department of Health and Human Services

Class 2 Device Recall 2 x 2 Elevating Monitor Suspension

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  Class 2 Device Recall 2 x 2 Elevating Monitor Suspension see related information
Date Initiated by Firm February 28, 2023
Date Posted October 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-0156-2024
Recall Event ID 93018
Product Classification Monitor, patient position, light-beam - Product Code IWE
Product Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Code Information all units manufactured between 10-22-2012 and 07-09-2019
Recalling Firm/
Manufacturer		 Omega Medical Imaging, Inc.
3400 Saint Johns Pkwy Ste 1020
Sanford FL 32771-6769
Manufacturer Reason
for Recall		 An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
FDA Determined
Cause 2		 Device Design
Action Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 02/28/2023 by email. The notice explained the issue and pledged to evaluate all potentially impacted devices and mitigate the issue to bring the boom systems up to the latest safety design and standard of the newer models approved for field use.
Quantity in Commerce 52 units
Distribution Worldwide distribution - US Nationwide and the country of Pakistan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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