Vivid i N ultrasound device batteries may fail, smoke, or catch fire
GE Medical Systems recalls Vivid i N ultrasound machines worldwide because unreplaced batteries may fail, emit smoke, or catch fire. Users should replace batteries every 2 years per the service manual.
What this means for you
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: FDA Class II device recall with no reported illnesses, injuries, or deaths. The hazard—battery failure leading to potential fire and smoke—is serious but theoretical. This meets the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Medical Systems is recalling certain Vivid i N ultrasound systems worldwide due to a battery hazard. Batteries in these devices that have not been replaced at the recommended 2-year interval, as specified in the Service Manual, may fail, emit smoke, or catch fire.
This recall affects 113 units distributed globally, including throughout the United States. The Vivid i N is used in multiple imaging applications including fetal/obstetric, cardiac, vascular, and musculoskeletal imaging.
GE Medical Systems and the FDA recommend that facilities using affected ultrasound devices inspect them immediately and follow the 2-year battery replacement schedule specified in the Service Manual. Operators should contact their GE representative or the FDA for specific guidance on their device.
The recalled product
- Product
- Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- fire
- battery-failure
- smoke
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)
- No US Distribution. Model Number H45561AC
- System ID: DZ1237US02
- AO1015US01
- EG1843US01
- EG5882US01
- EG1621US04
- EG1621US03
- 2538978U01
- 083038042857318
- 083038602007811
- 083038602826113
- 0835384095
- IQ1165US05
- IQ1376US01
- KE1049US01
- KW1010US04
- KW1102US04
- KW1001US35
- KW1011US21
- KW1011US22
Distribution
Distributed nationwide across the United States.
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