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GE Healthcare, LLC Recall 87811

Description: NM/CT 860 Nuclear Medicine / CT Scanners

GE Healthcare, LLC Recall 87811 Information

Mandated?FDA Mandated
Recall NumberZ-1546-2021
Event ID87811
Event DescriptionNM/CT 860 Nuclear Medicine / CT Scanners
Product TypeDevices
DistributionWorldwide distribution - US Nationwide
Quantity242 in total (17 units US)
Recall ReasonGE 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.
Device Classification20210519
Device Code InfoGTIN*00840682140751
Center Classification Date20210511
Recall Initiation Date20210207
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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