Device product
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
Z-1696-2017
Product summary
- Event
- Event 76763
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1696-2017
Official wording
Reason: Loosened monitor arm.
Code information: Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
Distribution pattern: Nationwide Distribution to PA, TX, FL, AZ, IN, OH
Derived failure modes
-
Unknown
Loosened monitor arm.