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Recall Observatory FDA recall evidence

Device product

The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.

Z-1188-2016

February 29, 2016

Class II

Product summary

Firm
Richard Wolf Medical Instruments Corp.
Event
Event 73348
Status
Terminated
Classification
Class II
Quantity
108 units
Official record key
device-enforcement:Z-1188-2016

Official wording

Reason: Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

Code information: FLEXION-PORT 400 (68cm) with Product number 32116068 and the following affected serial numbers: 001X001107, 001X001108, 001X001109, 001X001110, 001X001111, 001X001142, 001X001143, 001X001144, 001X001145, 001X001146, 001X001147, 001X001148, 001X001149, 001X001150, 001X001151, 001X001168, 001X001169, 001X001170, 001X001171, 001X001172, 001X001216, 001X001217, 001X001218, 001X001219, 001X001220, 001X001221, 001X001222, 001X001223, 001X001224, 001X001225, 001X001226, 001X001227, 001X001228, 001X001230, 001X001256, 001X001257, 001X001258, 001X001259, 001X001260, 001X001261, 001X001262, 001X001263, 001X001264, 001X001265, 001X001376, 001X001377, 001X001378, 001X001379, 001X001380, 001X001381, 001X001382, 001X001383, 001X001384, 001X001385 and 001X001229. FLEXION-PORT 300+350 (93cm) with Product number 32116093 and the following affected serial numbers: 001X001173, 001X001174, 001X001175, 001X001176, 001X001177, 001X001235, 001X001237, 001X001239, 001X001299, 001X001309, 001X001310, 001X001313, 001X001314, 001X001315, 001X001366, 001X001367, 001X001368, 001X001369, 001X001370, 001X001371, 001X001372, 001X001373, 001X001374, 001X001375, 001X001402, 001X001403, 001X001406, 001X001231, 001X001232, 001X001233, 001X001234, 001X001236, 001X001238, 001X001240, 001X001296, 001X001297, 001X001298, 001X001300, 001X001301, 001X001302, 001X001303, 001X001304, 001X001305, 001X001306, 001X001307, 001X001308, 001X001311, 001X001312, 001X001404, 001X001405, 001X001439, 001X001440, 001X001441, 001X001442, 001X001443, 001X001444, 001X001445, 001X001446, 001X001447 and 001X001448. FLEXION-PORT 400+350 (103cm) with Product number 32116103 and the following affected serial numbers: 001X001241, 001X001242, 001X001243, 001X001244, 001X001245, 001X001246, 001X001247, 001X001248, 001X001249, 001X001250, 001X001321, 001X001323, 001X001324, 001X001325, 001X001336, 001X001337, 001X001338, 001X001339, 001X001340, 001X001341, 001X001342, 001X001343, 001X001344, 001X001345, 001X001316, 001X001317, 001X001318, 001X001319, 001X001320 and 001X001322.

Distribution pattern: Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

Field note

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