The Recall Desk
ModerateFDA (Devices)·Z-0193-2015·Announced 2014-11-19

GE OEC MiniView 6800 C-Arm Recall for Component Revision

GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a field correction for potentially installed components without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

GE Healthcare is recalling 26 units of the OEC MiniView 6800 Digital Mobile C-Arm. This device is designed to provide physicians with general fluoroscopic visualization for surgical orthopedic and extremity imaging.

The recall was initiated as a field correction because prior revisions of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800, and OEC UroView 2800 systems. The affected units were distributed worldwide.

Facilities with these devices should contact GE OEC Medical Systems, Inc. for further instructions regarding the field correction.

The recalled product

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 imagin
Manufacturer
GE OEC Medical Systems, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
26

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 recalled by GE OEC Medical Systems, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · GE OEC Medical Systems, Inc

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Same hazard · component defect

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