Innovative Tomography Product GMBH FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KClass IIApr 21, 2021Sterility Assurance; Coaxial Interventional Needle labeled a	Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized	Class IIDevices	Apr 21, 2021
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KClass IIApr 21, 2021Sterility Assurance; Coaxial Interventional Needle labeled a	Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized	Class IIDevices	Apr 21, 2021
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIClass IIApr 21, 2021Sterility Assurance; Coaxial Interventional Needle labeled a	Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized	Class IIDevices	Apr 21, 2021