Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
FDA Recall Z-0156-2024 · Posted 2023-10-24
Recalling FirmOmega Medical Imaging, Inc.
Recall StatusOpen, Classified
Product CodeIWE
Date Initiated2023-02-28
Product Quantity52 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Pakistan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.