GE Vivid S5 Ultrasound Systems Battery Failure Fire Risk
GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or fire.
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 medical device recall involving potential battery failure with fire and smoke hazard. No illnesses, injuries, or reported incidents. Hazard is theoretical but serious.
Plain-English summary
GE Medical Systems, LLC is recalling Vivid S5 ultrasound systems used for diagnostic ultrasound imaging. Approximately 5,649 units have been distributed worldwide, including throughout all US states and territories.
The recall addresses a battery safety concern. Batteries that are not replaced at the 2-year interval recommended in the Service Manual may fail and could emit smoke or catch fire.
Affected users should review their device maintenance records to determine if batteries have been replaced according to the Service Manual schedule. Healthcare facilities and individual operators should contact GE Medical Systems for guidance on battery replacement procedures and any necessary service actions.
The recalled product
- Product
- Vivid S5 Ultrasound. 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 Conventional and Superf
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- battery-failure
- fire
- 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)
- Model Number (System ID): H45021LC (VS50873
- VS51169
- VS5227
- VS594
- VS5289
- VS544
- VS5155
- VS50058
- VS519
- VS551
- VS50589
- VS5286
- VS5317
- VS5299
- VS50954
- VS50940
- VS560
- VS50793
- VS50311
- VS50028
Distribution
Distributed nationwide across the United States.
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