GE Healthcare recalls NM/CT 870 DR Nuclear Medicine/CT Scanners that may shift CT radiation exposure by up to 5cm, potentially requiring additional scans. Affected units have specific model and serial numbers.
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 certain NM/CT 8:70 DR Nuclear Medicine/CT Scanners that could shift radiation exposure by up to 5cm during scans. This might require additional X-ray scans, increasing radiation exposure for patients.
The scanners may shift CT radiation exposure by up to 5cm during specific scans. This could lead to additional X-ray radiation exposure if the scan needs to be repeated.
Patients using the NM/CT 870 DR scanners with the specific hybrid whole-body continuous F3 protocol are at risk. Healthcare facilities that use these scanners for nuclear medicine or CT imaging may be affected.
Check for the NM/CT 870 DR Nuclear Medicine/CT Scanners with GTIN 00840682140836. The issue occurs only with the hybrid whole-body continuous F3 protocol using Zoom < 1 settings on the Smart Console.
Verify if your scanner uses the hybrid whole-body continuous F3 protocol with Zoom < 1 settings on the Smart Console.
No, the recall does not require immediate discontinuation. The issue only affects specific scan protocols.
The recall states the issue may require additional scans, but it does not mention serious injury risks.
Check for the NM/CT 870 DR scanners with GTIN 00840682140836 and the specific protocol settings mentioned in the recall.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1547-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1547-2021 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.
