Agency classClass IIOur severity:High FDA (Devices)·Z-2027-2012·Announced 2012-07-25

GE OEC 8800 Flexiview Imaging Device Recall for Defective Power Supply

GE OEC Medical Systems is recalling OEC 8800 Flexiview imaging devices because an FDA inspection found a defective vertical lift column power supply subject to early life failure.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a defective power supply subject to early life failure in a medical imaging device, which poses a risk of harm to patients or operators, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 1,349 units of the OEC 8800 Flexiview imaging device. The recall was initiated after an FDA inspection identified that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.

The affected devices were distributed worldwide. The recall includes all serial numbers for the OEC 8800. The source text notes that this is not a new recall, but the agency is now classifying the action due to administrative issues. The recall also covers the OEC 9900 and OEC 9800 models, though the specific unit counts for those models are not provided in this text.

Healthcare facilities and users should contact GE OEC Medical Systems for instructions on how to address the defective power supply. The recall is classified as Class II by the FDA.

The recalled product

Product: OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and…
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — Imaging Equipment
Hazard: electrical-defect
equipment-failure
Affected units: 1,349

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)

Part numbers: OEC 8800 All serial numbers.

Distribution

Distribution scope not specified by the agency.

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 · electrical defect