6 results
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57ms
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Sources: EU EUDAMED, US FDA
Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications
FDA Enforcement
Class II
·Terminated·Hitachi Aloka Medical, Ltd.·April 5, 2017
ARIETTA 60 AND ARIETTA 70
FDA Adverse Event
Malfunction
·HITACHI ALOKA MEDICAL, LTD.·Product code IYN·October 28, 2014
PROSOUND ALPHA-10
FDA Adverse Event
Malfunction
·HITACHI ALOKA MEDICAL LTD.·Product code IYN·May 30, 2013
PROSOUND F75 ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·HITACHI ALOKA MEDICAL, LTD·Product code GXX·July 16, 2014
Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications
FDA Recall
Terminated
·Hitachi Aloka Medical, Ltd.·Product code IYN·June 11, 2014
SSD-ALPHA10
FDA Adverse Event
Malfunction
·HITACHI ALOKA MEDICAL, LTD. AMERICA OFFICE·Product code IYN·October 30, 2011