FDA recall Z-2621-2017

Omega Medical Imaging, Inc. · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2017-03-23
Report date
2017-06-28
Termination date
2019-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sanford, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2017