GE Healthcare recalls 800 family NM/CT 850 scanners that could shift CT radiation exposure by up to 5cm in specific scans, potentially requiring re-scans. Affected units have GTIN 00840682140775.
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 800 family NM/CT 850 scanners that may shift CT radiation exposure by up to 5cm during specific scans. This could require additional X-ray scans, increasing radiation exposure for patients.
The scanners may shift CT radiation exposure by up to 5cm during specific scans where the Zoom setting is less than 1 and the scan range is set on the Smart Console. This could require additional X-ray scans, increasing radiation exposure for patients.
Patients using these scanners for nuclear medicine or CT scans may be affected. Those undergoing scans with the specific hybrid whole-body continuous F3 protocol are most at risk.
Check for the GTIN 00840682140775 on the scanner. Affected units use the hybrid whole-body continuous F3 protocol with Zoom < 1 and scan range set on the Smart Console.
Verify if your scanner uses the hybrid whole-body continuous F3 protocol with Zoom < 1 and scan range set on the Smart Console.
No, the recall does not require stopping use. The issue only affects specific scan settings.
The recall states this may require additional scans, but does not mention serious injury risks.
Check for the GTIN 00840682140775 and verify if your scanner uses the hybrid whole-body continuous F3 protocol with Zoom < 1 and scan range set on the Smart Console.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1545-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1545-2021 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.
