Class 2 Device Recall Omega Medical Imaging, LLC

• Date Initiated by Firm: September 08, 2023
• Date Posted: October 24, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0160-2024
• Recall Event ID: 93123
• Product Classification: Monitor, patient position, light-beam - Product Code IWE
• Product: Omega Medical Imaging Elevating Monitor Suspension Systems, 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
• For Additional Information Contact: Mr. Brian Fleming; 407-323-9400
• Manufacturer Reason for Recall: An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.
• FDA Determined Cause: Device Design
• Action: Omega Medical Imaging issued a Field Safety Advisory Notice to its consignees on 09/08/2023 via email. The notice explained the problem and the risk. The firm will inspect all affected devices to ensure the proper fasteners were installed on the unit.
• Quantity in Commerce: 31 units
• Distribution: Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
• 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.