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U.S. Department of Health and Human Services

Class 2 Device Recall 2 over 2 Elevating Monitor Suspension

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 Class 2 Device Recall 2 over 2 Elevating Monitor Suspensionsee related information
Date Initiated by FirmJune 21, 2016
Create DateSeptember 03, 2016
Recall Status1 Terminated 3 on October 04, 2019
Recall NumberZ-2734-2016
Recall Event ID 74886
Product Classification unknown device name - Product Code N/A
Product2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
Code Information Model: Elevating Monitor Suuspension P/Ns: 1000-0085, 1000-0095 and (1000-0129 one unit produced does not use bracket 1040-0071 or 1040-0031).
FEI Number 1000222289
Recalling Firm/
Manufacturer		 Omega Medical Imaging, Inc.
675 Hickman Cir
Sanford FL 32771-6931
For Additional Information ContactJohn Newman
407-323-9400
Manufacturer Reason
for Recall		Elevating Monitor Suspension separated from the lifting column bracket
FDA Determined
Cause 2		Device Design
ActionConsignees were notified by a Field Safety Advisory Notice - FSAN 16-0001 of this immediate Recall on 6/21/2016.
Quantity in Commerce26 units
DistributionCO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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