Device Recall Biograph Horizon PET/CT 의 리콜

Recall

79988

Class 2

Z-1597-2018

2018-01-26

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164139

Error introduced into pet images acquired and reconstructed with vj20a software. array values are indexed improperly when the norm file is created during qc. during data reconstruction, incorrect values are being applied. this can lead to a gradient in the image. the severity of the error is directly related to the positioning of the pet qc phantom relative to the center of the field of view.

Customers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall notice to the new owner.