FDA (Devices) recall action 97668
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
UIH Technologies is recalling two uCT ATLAS computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling 11 uCT 760 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling four uMI Panorama 35 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling 95 uMI 550 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling two uEXPLORER PET/CT systems because third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference.
UIH Technologies is recalling eight uCT 530 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling two uCT 780 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling three uMI 780 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
UIH Technologies is recalling 22 uCT 550 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.