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Recall Observatory FDA recall evidence

Device product

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

Z-2734-2016

June 21, 2016

Class II

Product summary

Firm
Omega Medical Imaging, Inc.
Event
Event 74886
Status
Terminated
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-2734-2016

Official wording

Reason: Elevating Monitor Suspension separated from the lifting column bracket

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).

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Elevating Monitor Suspension separated from the lifting column bracket