GE Healthcare recalls Discovery NM 630 nuclear imaging systems due to potential detector mounting failure during installation, which could compromise safety. Affected units have specific model and serial numbers listed in the recall notice.
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 Discovery NM 630 nuclear imaging systems because some detector screws may not have been secured properly during installation. This could lead to loss of one detector mounting design redundancy, potentially affecting system safety during medical procedures.
During installation of certain Nuclear Medicine systems with dismounted detectors, some detector screws may not have been secured correctly. This could result in the loss of one detector mounting design redundancy, which might compromise the system's safety during medical imaging procedures.
Healthcare facilities that own or use the Discovery NM 630 nuclear imaging system are likely affected. Medical professionals and patients using these systems may be at risk if the detector mounting issue occurs.
Check for specific model and serial numbers listed in the recall notice, including 63GY50074, 63GX50024, 630X22925, and other combinations with H3101RH or H3100JY identifiers. The systems were sold with specific lot or serial numbers as detailed in the product list.
Review the model and serial numbers listed in the recall notice to confirm if your Discovery NM 630 system is affected.
The recall is due to potential detector mounting failure during installation, which could lead to loss of one detector mounting design redundancy.
Affected models include 63GY50074, 63GX50024, 630X22925, and other combinations with H3101RH or H3100JY identifiers as listed in the recall notice.
The recall does not specify a remedy, so no immediate action is required beyond checking if your system is listed in the affected models.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1257-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1257-2019 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.