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FDA Device recall Z-0193-2015

OEC¿ MiniView 6800

On 2014-11-19 the FDA classified a Class II recall of OEC¿ MiniView 6800 by Ge Oec Medical Systems, citing 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 2….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0193-2015
ClassificationClass II
Statusterminated
Initiated2014-10-03
Published2014-11-19
Last updated2026-09-13 11:53 UTC
CompanyGe Oec Medical Systems
Distributionn/a

Product

OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.

Reason

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.

Identifiers

code_info
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,86-1129,8…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0193-2015%22

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