UIH Technologies uMI 550 MD PET/CT Recalled for 95 Units Over Mechanical Interference Risk (2025)
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
1,320 recalls tagged with “fda regulated”.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Possible presence of stones in product
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Possible presence of stones in product
Tablet/Capsules Imprinted with Wrong ID
Tablet/Capsules Imprinted with Wrong ID
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.