GE Healthcare recalls NM/CT 860 scanners that may shift CT radiation exposure by up to 5cm, risking extra X-rays during specific scans. Affected units sold with GTIN 00840682140751.
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
GE Healthcare is recalling NM/CT 860 scanners that could shift radiation exposure by up to 5cm during specific scans, potentially requiring extra X-rays. This affects patients undergoing certain imaging procedures with the hybrid whole-body continuous F3 protocol.
The scanners may shift radiation exposure by up to 5cm during specific imaging workflows. This could lead to extra X-ray exposure for patients if the scan range is set incorrectly on the Smart Console.
Patients using the NM/CT 860 scanners with the hybrid whole-body continuous F3 protocol (Zoom < 1) are most at risk. Healthcare facilities that perform these specific scans may need to re-scan patients.
Check for the NM/CT 860 scanner model with GTIN 00840682140751. The issue occurs only with the hybrid whole-body continuous F3 protocol when Zoom settings are below 1.
Verify if your scanner uses the hybrid whole-body continuous F3 protocol with Zoom settings below 1.
No, the recall does not require immediate discontinuation. The issue only affects specific scan protocols.
The recall states the issue may require a re-scan, but it does not mention risk of serious injury or death.
Check for the NM/CT 860 model with GTIN 00840682140751 and the hybrid whole-body continuous F3 protocol with Zoom settings below 1.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1546-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1546-2021 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.
