Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2629-2016·Announced 2016-08-31

GE OEC 9800 Fluoroscopic X-Ray System Recalled for Monitor Firmware Issue

GE OEC Medical Systems is recalling 47 OEC 9800 fluoroscopic x-ray systems because a firmware issue may cause the LCD workstation monitors to appear dark with no video displayed.

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 the hazard is a functional failure (dark screen) without reported injuries or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 47 OEC 9800 fluoroscopic x-ray systems. The recall is due to a firmware issue in the supplied LCD workstation monitors. Under some circumstances, the monitors may appear dark with no video displayed.

The affected units were distributed in the United States nationwide and in Korea. The recall involves specific monitor part numbers, including 5448359-01, 5459219-01, and 5475662-03, among others.

No specific instructions for consumers are provided in the source text, as this is a medical device recall managed by the manufacturer and healthcare facilities.

The recalled product

Product: OEC 9800, fluoroscopic x-ray system
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — Imaging Equipment
Hazard: firmware-defect
display-failure
Affected units: 47

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)

monitor part numbers: 5448359-01
5459219-01
or 5475662-03:89-3853
82-1593
8S-1935
89-3356
89-1323
8S-2885
82-0700
8S-1708
82-0420
82-1998
8S-2027
82-7101-MH
8S-2670
P6-0375-L
8S-1614
89-0846
82-0576
82-3256

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · GE OEC Medical Systems, Inc

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Same hazard · firmware defect