GE OEC Fluoroscopes Recalled for Snubber Board Safety Standard Non-Compliance
GE OEC Medical Systems is recalling 845 fluoroscopes because the Snubber Board does not meet IEC 60601-1 safety standards for voltage isolation.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or deaths, and the hazard is a technical non-compliance with safety standards rather than a reported acute failure.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 845 units of GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes. These devices are used for image intensified fluoroscopic x-rays for interventional radiologic procedures. The recall covers units distributed worldwide and nationwide in the USA.
The recall was initiated because the Snubber Board, a printed circuit board (PCB) with a 70 amp fuse designed to protect internal system components from high voltage, did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. This non-compliance relates to the electrical safety of the device's high voltage system components, such as the X-ray tube or High Voltage Transformer.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. The specific serial numbers range from 69-0128 to ES-7039-MH. Users should contact GE OEC Medical Systems for instructions on how to address the non-conforming Snubber Board.
The recalled product
- Product
- GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubb
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 845
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 numbers: 69-0128
- 82-0157
- 82-0158
- 82-0185
- 82-0191
- 82-0210
- 82-0215
- 82-0223
- 82-0229
- 82-0266
- 82-0324
- 82-0328
- 82-0464
- 82-0477
- 82-0484
- 82-0505-RC
- 82-0507
- 82-0542
- 82-0544
- 82-0546
Distribution
Distributed nationwide across the United States.
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