Recall Z-2621-2017 ยท IWE Monitor, Patient Position, Light-Beam
Omega Medical Imaging, Inc.
Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals.
| Date | Jun 19, 2017 (initiated Mar 23, 2017) |
| Status | Terminated |
| Reason | Elevating Monitor Suspension column dropping and will not rise back up. |
| Root cause | Mixed-up of materials/components |
| 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 jnewman@omegamedicalimaging.com at Omega. Product is to be corrected. If there are any questions or concer |
| Quantity | 6 units |
| Distribution | Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.