4 results
·
60ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
FDA Recall
Terminated
·Siemens Hearing Instruments, Inc·Product code LEZ·July 1, 2005
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
FDA Enforcement
Class II
·Terminated·Siemens Hearing Instruments, Inc·February 26, 2014
Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 22, 2009
Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061 Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·April 22, 2009