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Hitachi Aloka Medical, Ltd. recalls Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sono
Recalled April 5, 2017 · FDA recall Z-1696-2017 · Hitachi Aloka Medical
Hazard
Loosened monitor arm. · FDA Class II
Sold at
Nationwide Distribution to PA, TX, FL, AZ, IN, OH
Description
Loosened monitor arm.
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
Manufacturer(s)
Hitachi Aloka Medical, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →