GE Healthcare recalls Optima NM/CT 640 nuclear medicine systems with certain serial numbers due to potential detector fall risk from improper relocation. Affected units may require inspection or repair to prevent serious injury.
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 specific models of Optima NM/CT 640 nuclear medicine systems. These systems could have been moved without proper detector support, potentially causing the detector to fall and leading to serious injury. Affected units have unique serial numbers listed in the recall.
The recall addresses a risk that certain Optima NM/CT 640 systems could have been transported or relocated without proper detector support. This may cause excessive load on the detector mounting mechanisms, potentially leading to the detector falling and causing serious injury.
Healthcare facilities using GE Healthcare Optima NM/CT 640 nuclear medicine systems with the specific serial numbers listed in the recall are most at risk. Patients and staff using these systems could be affected if the detector falls.
Check if your GE Healthcare Optima NM/CT 640 system has a serial number matching those listed in the recall. The serial numbers are detailed in the product description with system IDs and serial numbers.
Identify your system's serial number and system ID to confirm if it's affected by this recall.
Reach out to GE Healthcare for guidance on next steps if your system is affected.
The recall affects GE Healthcare Optima NM/CT 640 nuclear medicine systems with specific serial numbers listed in the product description.
Check your system's serial number and system ID against the list of affected units provided in the recall description.
Contact GE Healthcare directly for instructions on next steps, as the recall does not specify a repair or replacement process.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0896-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0896-2025 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.
