FDA Enforcement
Class II
Terminated
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
Recall: Z-1696-2017
·
Reported April 5, 2017
Enforcement
- Recall Number
- Z-1696-2017
- Event ID
- 76763
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hitachi Aloka Medical, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 5, 2017
- Initiation Date
- June 11, 2014
- Classification Date
- March 29, 2017
- Termination Date
- July 3, 2017
- Address
- 10 Fairfield Blvd, Wallingford, CT, 06492-5903, United States
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
Loosened monitor arm.
Code Info
Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
Distribution
Nationwide Distribution to PA, TX, FL, AZ, IN, OH