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Recall Observatory FDA recall evidence

Device product

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

Z-1696-2017

June 11, 2014

Class II

Product summary

Firm
Hitachi Aloka Medical, Ltd.
Event
Event 76763
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1696-2017

Official wording

Reason: Loosened monitor arm.

Code information: Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Loosened monitor arm.