GE Healthcare recalls NM/CT 850 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 NM/CT 850 nuclear medicine 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, which might impact system safety during use.
During installation, some detector screws in the NM/CT 850 system may not have been secured correctly. This could cause the loss of one detector mounting design redundancy, potentially affecting the system's safety and performance during imaging procedures.
Healthcare facilities using GE NM/CT 850 systems for nuclear medicine imaging procedures are likely affected. Medical staff and patients using these systems are at risk if the detector mounting issue occurs.
Check for the model numbers listed in the recall notice: 85EX67018, 85EX67001, 850X61005, 850Y61006, 85EX67022, 85EX67019, 85EX67008, 85EX67017, 85EX67012, 85EX67015, 85EX67020, 85EX67023, 85EX67024, 85EY67025, 85EY67026, 85EY67028, 85EX67009, 85EX67002, 85EX67016, 85EX67004, 85EX67021, 85EX67010, 85EX67011, 85EX67005, 85EX67013, 850X61004, 850X61002, NT3BG1900001BH, 85EX67003, 85EX67014, 850Y61007.
Identify your NM/CT 850 system model number to see if it is listed in the recall notice.
Reach out to GE Healthcare for guidance on whether your system needs correction or if it is safe to continue using.
The recall is due to potential detector mounting issues during installation that could lead to loss of one detector mounting design redundancy.
The affected models include 85EX67018, 85EX67001, 850X61005, 850Y61006, and others listed in the recall notice.
No, the recall does not require immediate discontinuation. Contact GE Healthcare for specific guidance on your system.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1262-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1262-2019 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.