| Class 2 Device Recall Prosound F75 or F75 | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYN
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