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U.S. Department of Health and Human Services

Class 2 Device Recall Omega Medical Imaging, LLC

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 Class 2 Device Recall Omega Medical Imaging, LLCsee related information
Date Initiated by FirmSeptember 08, 2023
Date PostedOctober 24, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0160-2024
Recall Event ID 93123
Product Classification Monitor, patient position, light-beam - Product Code IWE
ProductOmega 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 ContactMr. 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 2
Device Design
ActionOmega 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 Commerce31 units
DistributionAlabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma
Total Product Life CycleTPLC 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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