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…

Recall date

June 11, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1696-2017

FDA classification

Class II

Brand / firm

Hitachi Aloka Medical, Ltd.

Sold / distributed

Nationwide Distribution to PA, TX, FL, AZ, IN, OH

Why it was recalled

Loosened monitor arm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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