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Open, Classified

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

FDA Recall Z-0160-2024 · Posted 2023-10-24

Recalling FirmOmega Medical Imaging, Inc.
Recall StatusOpen, Classified
Product CodeIWE
Date Initiated2023-09-08
Product Quantity31 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Alabama, California, Illinois, Indiana, Kentucky, Louisiana, Missouri, Montana, North Carolina, Ohio, Oklahoma

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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