GE Healthcare recalls Brivo NM 615 nuclear medicine systems with specific model numbers due to potential detector fall risk from improper relocation. Affected units may cause life-threatening injury if detector falls.
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
GE Healthcare is recalling certain Brivo NM 615 nuclear medicine systems that could fall if improperly relocated, potentially causing serious injury. Owners should check their model numbers against the list provided to determine if their unit is affected.
If the system is moved or relocated without proper detector support, excessive load can be applied to the detector mounting. This may cause the detector to fall, leading to life-threatening injury.
Healthcare facilities using the Brivo NM 615 nuclear medicine systems with model numbers 5376204-15, H2401MA, or H3100TA are most at risk. These systems are used in medical imaging settings where improper relocation could cause detector falls.
Check if your Brivo NM 615 system has model numbers 5376204-15, H2401MA, or H3100TA. The system may have specific serial numbers listed in the recall details.
Identify your Brivo NM 615 system's model number from the list: 5376204-15, H2401MA, or H3100TA.
Reach out to GE Healthcare for further assistance if your system is affected.
The affected model numbers are 5376204-15, H2401MA, and H3100TA.
The recall is due to the risk of detector falls if the system is moved or relocated without proper detector support, which could cause life-threatening injury.
No, but if your system is affected, you should check with GE Healthcare to ensure proper handling.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0889-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0889-2025 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.
