GE Healthcare recalls Optima PET/CT 560 and 560FX systems due to potential x-ray exposure without stopping during scans. Affected units may cause unnecessary radiation exposure to patients and staff.
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
GE Healthcare is recalling its Optima PET/CT 560 and 560FX imaging systems because they may allow x-ray exposure to continue without stopping during scans. This could lead to unnecessary radiation exposure for patients and staff during medical procedures.
The systems are designed for head and whole body PET/CT imaging but may not stop x-ray exposure when the scan is complete. This could result in additional radiation exposure to patients and medical personnel during procedures.
Medical facilities using the Optima PET/CT 560 or 560FX systems are most at risk. Patients and staff involved in scans may be exposed to unnecessary radiation.
Check for the Optima PET/CT 560 or 560FX models. These systems are used for head and whole body PET imaging with integrated CT scans.
Verify if the system stops x-ray exposure when scans are complete by consulting with your facility's imaging team.
The systems may allow x-ray exposure to continue without stopping during scans, potentially causing unnecessary radiation exposure.
Facilities should check if their Optima PET/CT 560 or 560FX systems stop x-ray exposure when scans are complete.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1747-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1747-2019 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.
