PlainRecalls
FDA Devices Moderate Class II Ongoing

NM/CT 860 Nuclear Medicine / CT Scanners

Reported: May 19, 2021 Initiated: February 7, 2021 #Z-1546-2021

Product Description

NM/CT 860 Nuclear Medicine / CT Scanners

Reason for Recall

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
242 in total (17 units US)
Distribution
Worldwide distribution - US Nationwide
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
NM/CT 860 Nuclear Medicine / CT Scanners. Recalled by GE Healthcare, LLC. Units affected: 242 in total (17 units US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Moderate. Recall number: Z-1546-2021.

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