Agency classClass IOur severity:Severe FDA (Devices)·Z-2038-2012·Announced 2012-08-01

GE OEC 9800 C-arm Systems Recalled for Power Supply Defect

GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which corresponds to a 'Severe' severity score (4) under the rubric, as Class I recalls represent a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Plain-English summary

GE OEC Medical Systems, Inc. is recalling 8,214 units of the OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800 MD Motorized C-arm Systems. These are image-intensified fluoroscopic x-ray systems designed for diagnostic, surgical, and interventional procedures. The affected units were distributed worldwide.

The recall is due to a defect in the vertical lift column power supply located in the mainframe C-arm of the device. The source text states that this component is subject to early life failure. The FDA has classified this recall as Class I, noting that the firm has taken action but the recall is being formally classified by the Agency due to administrative issues.

Healthcare facilities and users of these devices should contact GE OEC Medical Systems for further instructions on how to address the defective power supply. No specific consumer actions are detailed in the source text beyond the recall classification and the identification of the defective component.

The recalled product

Product: OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional…
Manufacturer: GE OEC Medical Systems, Inc
Category: Medical Device — Fluoroscopic X-ray System
Hazard: power-supply-failure
Affected units: 8,214

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)

8S-1663
8S-2887
89-3119
89-0098
8S-0152-C
89-0540
82-1252
82-1519
89-2326
89-1204
89-3272
89-3273
8S-0258
82-0678
82-1884
8S-2321
82-2042
82-3210
8S-0533
8S-1077

Distribution

Distribution scope not specified by the agency.

Same manufacturer · GE OEC Medical Systems, Inc

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Same hazard · power supply failure