FDA Recall Terminated

Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

Recall: Z-2621-2017 · Initiated March 23, 2017

Recall

Recall Number
Z-2621-2017
Event Number
77458
Firm
Omega Medical Imaging, Inc.
FEI Number
1000222289
Product Code
IWE
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
March 23, 2017
Posted
June 19, 2017
Terminated
December 11, 2019
Address
675 Hickman Cir, Sanford, FL, 32771-6931

Description

Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.

Reason

Elevating Monitor Suspension column dropping and will not rise back up.

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].

Distribution

Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.

Quantity

6 units