PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system) 의 리콜

Recall

RC-2014-RN-00014-1

Class I

2014-01-09

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00014-1

Ge healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the list mode replay feature of the discovery 600 and discovery 690. a software issue exists when using list mode replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions and may lead to image misinterpretation and/or inaccurate treatment decisions.

To avoid this potential issue, GE Healthcare is advising customers to implement temporary workaround instructions through the customer letters. GE Healthcare will provide a software update for all affected systems to address the issue permanently.