FDAFDA · Food and drugs·Recall number Z-1696-2017
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
Published April 5, 2017 · Recall initiated: June 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Loosened monitor arm.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hitachi Aloka Medical, Ltd.
- Distributor
- Nationwide Distribution to PA, TX, FL, AZ, IN, OH
- Lot
- Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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