GE Medical Systems recalls Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems due to potential X-ray abort errors causing imaging loss during procedures. Affected units have specific model and lot numbers.
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
GE Medical Systems is recalling certain Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems because they may experience X-ray abort errors that could cause imaging to stop unexpectedly during use. This risk could lead to incomplete procedures or safety issues for medical staff and patients.
These X-ray systems may stop imaging unexpectedly during procedures due to X-ray abort errors. This could cause incomplete medical procedures, potentially leading to safety risks for patients and medical staff if the imaging is needed for critical steps.
Medical facilities using the Innova IGS 630, 520, 530, or 540 Interventional Fluoroscopic X-ray Systems are most at risk. Patients and medical staff during procedures using these systems could be affected.
Check if your system has the Innova IGS 630, 520, 530, or 540 model with specific lot numbers listed in the recall notice. The model numbers and system IDs are provided in the detailed list.
Verify if your system has the specific model numbers and lot numbers listed in the recall notice.
The systems may experience X-ray abort errors that could cause imaging to stop unexpectedly during procedures.
Innova IGS 630, 520, 530, and 540 models with specific lot numbers listed in the recall notice.
No immediate stop is required, but affected systems should be checked for the specific lot numbers listed in the recall notice.
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-2387-2018 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2387-2018 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.
