Recall Z-1696-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Hitachi Aloka Medical, Ltd.
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
| Date | Jun 11, 2014 |
| Status | Terminated |
| Reason | Loosened monitor arm. |
| Root cause | Process control |
| Action | Hitachi Loki Medical sent a customer letter dated June 11, 2014, to affected consignees. The letter informed consignees of the issue and actions the firm planned to take. For questions regarding this recall call 888-782-5652. |
| Distribution | Nationwide Distribution to PA, TX, FL, AZ, IN, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM Hitachi Aloka Medical, Ltd., Jan 18, 2013 |