GE Medical Systems recalls Vivid i ultrasound systems with certain model numbers due to potential battery failure or fire risk if not replaced every 2 years as recommended in the service manual.
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
GE Medical Systems is recalling Vivid i ultrasound systems with specific model numbers because batteries not replaced every two years as per the service manual could fail or catch fire. This hazard affects medical imaging equipment used in various clinical settings.
Batteries in Vivid i ultrasound systems that have not been replaced every two years as specified in the service manual can fail or emit smoke, potentially leading to fire. This hazard occurs because the batteries degrade over time and may not function safely without regular replacement.
Healthcare providers using Vivid i ultrasound systems for medical imaging in obstetrics, abdominal/gynecology, pediatrics, and other specialties are most at risk. Patients using these systems for diagnostic imaging may also be affected.
Check if your Vivid i ultrasound system has model numbers listed in the 510(k) numbers provided (K033139, K061525, K082374, K092140, K102388, K121062) or the specific model numbers (H45021A, H45021AF, H45021JK, H45021JL, H45021KC, H45021WP).
Review the service manual to confirm if your Vivid i ultrasound system's batteries were replaced within the last two years.
If batteries were not replaced within two years, replace them immediately following the service manual instructions.
Batteries in Vivid i ultrasound systems that have not been replaced every two years as recommended in the service manual can fail or emit smoke, potentially leading to fire.
Check if your system has model numbers listed in the 510(k) numbers provided (K033139, K061525, K082374, K092140, K102388, K121062) or the specific model numbers (H45021A, H45021AF, H45021JK, H45021JL, H45021KC, H45021WP).
No, you do not need to stop using it immediately. However, if batteries were not replaced within two years, you should replace them as soon as possible to prevent potential fire risks.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0756-2023 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-0756-2023 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
