Z-1696-2017Class II

Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel...

Name: Z-1696-2017 Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel...
Creator: Hitachi Aloka Medical, Ltd.
Published: 2014-06-11
License: https://open.fda.gov/license/

Hitachi Aloka Medical, Ltd. / initiated 2014-06-11 / Terminated / root cause: manufacturing process

FDA source

Hitachi Aloka Medical, Ltd. began a recall of Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic... on 2014-06-11. FDA classified it as Class II and gives the reason as "Loosened monitor arm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1696-2017
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Posted: 2017-03-29
Terminated: 2017-07-03
Recalling firm: Hitachi Aloka Medical, Ltd.
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Loosened monitor arm.
Root cause tag: manufacturing process
FDA 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
Product codes and lots: Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1696-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-29

Product code IYN

K123828Class IIProsound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. / cleared 2013-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)