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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

FDA Recall Z-1696-2017 · Posted None

Recalling FirmHitachi Aloka Medical, Ltd.
Recall StatusTerminated
Product CodeIYN
Date Initiated2014-06-11
Date Terminated2017-07-03

Reason for Recall

Loosened monitor arm.

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123828PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMHitachi Aloka Medical, Ltd. · 2013-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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