Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates mon

FDA device recall Z-2621-2017 · posted 2017-06-19 · Terminated

Recall details

Recalling firm

Omega Medical Imaging, Inc.

Reason for recall

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

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

IWE

Quantity affected

6 units

Distribution

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

Date initiated

2017-03-23

Date posted

2017-06-19

Date terminated

2019-12-11

Location

Sanford, FL