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Z-2734-2016 Class II Terminated

Recalled by Omega Medical Imaging, Inc. — Sanford, FL

FDA device recall Z-2734-2016 was initiated by Omega Medical Imaging, Inc. on June 21, 2016 and is designated Class II. Reason for recall: Elevating Monitor Suspension separated from the lifting column bracket The recall status is terminated (terminated October 4, 2019). Affected quantity: 26 units.

Recall Details

Product Type: Devices
Report Date: September 14, 2016
Initiation Date: June 21, 2016
Termination Date: October 4, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26 units

Product Description

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

Reason for Recall

Elevating Monitor Suspension separated from the lifting column bracket

Distribution Pattern

CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark

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).