Device Recall GEMINI GXL PET/CT Scanners

The affected Serial Numbers are:  4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175.

Radiology Devices

2

No

Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, and Sweden.

Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.