GE Healthcare recalls Optima NM/CT 640 nuclear medicine imaging systems due to potential detector mounting issues that could affect safety during installation. Learn what to do if you own this equipment.
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
GE Healthcare is recalling certain Optima NM/CT 640 nuclear medicine imaging systems because some detector screws may not be secured properly during installation. This could lead to loss of one detector mounting design redundancy, which might affect system safety during use.
During installation of certain systems with dismounted detectors, some detector screws may not be secured correctly. This could lead to loss of one detector mounting design redundancy, potentially affecting the system's safety during imaging procedures.
Healthcare facilities that own or use the recalled Optima NM/CT 640 nuclear medicine imaging systems are most at risk. Patients and staff could be affected if the system malfunctions during imaging procedures.
Check for the system model numbers listed in the recall notice, such as ONMX26520, ONMX26518, or ONMX26528. These systems were sold with specific serial numbers and lot codes between 2019 and 2021.
Verify your system's model number against the list of affected serial numbers provided in the recall notice.
The recall is due to potential improper installation of detector screws during certain nuclear medicine system installations, which could lead to loss of one detector mounting design redundancy.
Check your system's model number against the list of affected serial numbers provided in the recall notice. If you have an affected model, contact GE Healthcare for further instructions.
The recall indicates a potential safety issue but does not specify a risk of serious injury. The hazard is described as a possible loss of detector mounting redundancy, which may affect system safety during imaging procedures.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1266-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1266-2019 from GE Healthcare. 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.
