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U.S. Department of Health and Human Services

Class 2 Device Recall UST5550R Ultrasound Transducer,

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  Class 2 Device Recall UST5550R Ultrasound Transducer, see related information
Date Initiated by Firm October 20, 2017
Create Date March 01, 2018
Recall Status1 Terminated 3 on April 16, 2020
Recall Number Z-0816-2018
Recall Event ID 79160
510(K)Number K152126  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
Code Information 17 21 32 37 38 39 41 43 45 46 48 57 58 59 61 63 64 69 73 77 78 81 82 86 87 92 96 97 99 107 108 109 114 115 116 118 120 121 122 126 129 130 132 135 139 140 141 143 144 147 148 151 155 
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Douglas J. Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		 The ultrasound probe may not have adequate protection against electrical shock hazards.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Hitachi must recall the lot of UST-5550-R Transducers from S/N 1 to S/N 155. If you have a serial number in this range, please contact Hitachi Service at (800) 800-4925 to schedule the recall. Hitachi Sales will contact you regarding the options for a replacement transducer.
Quantity in Commerce 55
Distribution Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.
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 = ITX and Original Applicant = HITACHI ALOKA MEDICAL AMERICA, INC.
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