GE Healthcare Recalls OEC 8800 Mobile X-ray Systems for Linearity Defect
GE Healthcare is recalling 175 OEC 8800 Mobile Fluoroscopic X-ray Systems worldwide because they did not meet manufacturer specifications for linearity.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving a technical specification failure.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 175 units of the GEHC OEC 8800 Mobile Fluoroscopic X-ray System. These devices are used for mobile fluoroscopic examination of human anatomy. The recall is due to a defect where the X-ray units did not meet the manufacturer's specification for linearity.
The affected units were distributed worldwide, including in the United States, Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada. The recall is classified as FDA Class II.
Healthcare facilities should contact GE OEC Medical Systems, Inc. for instructions on how to address the linearity defect in the affected serial numbers.
The recalled product
- Product
- GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 175
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: 2791PU2
- 2797PU9
- 2817PU5
- 2824PU1
- 2827PU4
- 2899PU3
- 2900PU9
- 2901PU7
- 2918PU1
- 2919PU9
- 2922PU3
- 2939PU7
- 3095PU7
- 3103PU9
- 3107PU0
- 3219PU3
- 3223PU5
- 3224PU3
- 3230PU0
- 3233PU4
Distribution
Distribution scope not specified by the agency.
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