Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
FDA Recall Z-2621-2017 · Posted 2017-06-19
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Recalling FirmOmega Medical Imaging, Inc.
Recall StatusTerminated
Product CodeIWE
Date Initiated2017-03-23
Date Terminated2019-12-11
Product Quantity6 units
Reason for Recall
Elevating Monitor Suspension column dropping and will not rise back up.
Firm Action
The firm, OMEGA MEDICAL IMAGING, sent a "Field Safety Advisory Notice" dated 3/23/2017 to consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to immediately examine the product and confirm correct product information; immediately discontinue use; move monitor suspension away from staff personnel and patients; and advising consignees to take photos of affected product and the P/N label. Photos of product labels are to be sent to [email protected] at Omega. Product is to be corrected.
If there are any questions or concerns, please feel free to contact us at 407-323-9400 Ext 203 or email: omegamedicalimaging.com or [email protected].
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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