Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
This recall has been terminated (originally issued June 19, 2017).
- Company
- Omega Medical Imaging, Inc.
- Recall Initiated
- March 23, 2017
- Posted
- June 19, 2017
- Terminated
- December 11, 2019
- Recall Number
- Z-2621-2017
- Quantity
- 6 units
- Firm Location
- Sanford, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Elevating Monitor Suspension column dropping and will not rise back up.
Distribution
Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
Lot / Code Info
SKF Telescopic Pillar P/N ending in -003
Root Cause
Mixed-up of materials/components
Action Taken
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 jnewman@omegamedicalimaging.com 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 jnewman@omegamedicalimaging.com.