Z-1696-2017 Class II Terminated
FDA device recall Z-1696-2017 was initiated by Hitachi Aloka Medical, Ltd. on June 11, 2014 and is designated Class II. Reason for recall: Loosened monitor arm. The recall status is terminated (terminated July 3, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- June 11, 2014
- Termination Date
- July 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Loosened monitor arm.
Distribution Pattern
Nationwide Distribution to PA, TX, FL, AZ, IN, OH
Code Information
Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894