Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0974-2017·Announced 2017-01-18

GE OEC MiniView 6800 C-Arm Recalled for Power Cable Failures

GE Healthcare is conducting a voluntary field action for OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 devices due to intermittent power cord failures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 and is described as a voluntary field action for a power cable defect. No injuries, deaths, or specific adverse health consequences are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GE Healthcare Surgery has announced a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 digital mobile C-arm systems. The recall is being conducted because the workstation power cable assembly can result in intermittent power cord failures.

The affected devices were manufactured between January 1, 2016, and November 1, 2016. These units were distributed worldwide, including across the United States and internationally to Canada, Mexico, and Costa Rica.

The source text does not specify the exact remediation steps or contact information for affected users. Healthcare facilities should monitor official FDA channels or contact the manufacturer directly for specific instructions regarding the field action.

The recalled product

Product: OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 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…
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — Imaging Equipment
Hazard: power-cord-failure

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 (1)

Manufactured between 1/1/16 to 11/1/16

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · GE OEC Medical Systems, Inc

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Same hazard · power cord failure