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U.S. Department of Health and Human Services

Class 2 Device Recall Prosound F75 or F75

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  Class 2 Device Recall Prosound F75 or F75 see related information
Date Initiated by Firm June 11, 2014
Create Date March 29, 2017
Recall Status1 Terminated 3 on July 03, 2017
Recall Number Z-1696-2017
Recall Event ID 76763
510(K)Number K123828  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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
Code Information Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894 
Recalling Firm/
Manufacturer		 Hitachi Aloka Medical, Ltd.
10 Fairfield Blvd
Wallingford CT 06492-5903
For Additional Information Contact
888-782-5652
Manufacturer Reason
for Recall		 Loosened monitor arm.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = HITACHI ALOKA MEDICAL, LTD.
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