FDAClass IINovember 19, 2014

OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm recall

OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient…

Why was OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm recalled?

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial No: 86-0039,86-0135,86-0191,86-0318,86-0334,86-0587,86-0611,86-0619,86-0758,86-0782,86-0931,86-0935-RC,86-1129,86-1220,86-1241,86-1376,86-1432,86-1503,86-1551,86-1614,86-1678,86-1702,86-1736,86-1959,86-2092,86-2119

Product
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient…
Recalling firm
GE OEC Medical Systems, Inc
Quantity
26
Distribution
Worldwide Distribution.
Recall date
November 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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