ClearanceBrief
Recall Z-2734-2016 ยท N/A

Omega Medical Imaging, Inc.

2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

DateJun 21, 2016
StatusTerminated
ReasonElevating Monitor Suspension separated from the lifting column bracket
Root causeDevice Design
ActionConsignees were notified by a Field Safety Advisory Notice - FSAN 16-0001 of this immediate Recall on 6/21/2016.
Quantity26 units
DistributionCO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.