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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi

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  Class 2 Device Recall Hitachi see related information
Date Initiated by Firm June 30, 2021
Create Date August 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-2308-2021
Recall Event ID 88367
510(K)Number K183456  K173739  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during
robotic/non-robotic intra-operative and laparoscopic procedures
Code Information Serial Numbers: 20504835, 20504836, 20504837, 20504838, 20504839, 20556338, 20556369, 20556370, 20615320, 20615321, 20639217, 20639218, 20639219, 20639223, 20639224, 20639225, 20639226, 20639230, 20665290, 20693154, 20693155, 20693156, 20693157, 20693158, 20693159, 20693160, 20693161, 206E0051, 206E0058, 206E0059, 203R8980, 203R8981, 203R8986, 203R8987, 203R8988, 203R9022, 203R9023, 203R9031, 203R9032, 203R9033, 203R9034, 203R9035, 203R9036, 203R9037, 203R9038, 203R9041, 203R9042, 203R9047, 203R9048, 204J8480, 204J8481, 204J8482, 204J8483, 204J8484, 204Q3434, 204Q3435, 204S3741, 204S3742, 204S3746, 204S3747, 204S3755, 204S3757, 204S3758, 204S3759, 204S3760, 204S3773, 204U7420, 205B5697, 205B5703, 205B5713, 205F1090, 205F1091, 205F1092, 205F1093, 205F1095, 205F1097, 205F1109, 205F1110, 205F1119, 205Q9088, 205Q9089, 205Q9090, 205Q9091, 205Q9099, 206G6141, 206G6149, 206G6150, 206G6151, 206G6152, 206G6153, 206G6154, 206G6155, 206G6156, 206G6157, 206G6158, 206G6164, 206G6166, G3002072, G3002073, G3002074, G3002076, G3002077, G3002078, G3002079, G3002080, G3002081, G3002082, G3002083, G3002084, G3002086, G3002087, G3002088, G3002089, G3002090, G3002091, G3009910, G3009911, G3009972, G3009973, G3009974, G3020256, G3020257, G3020265, G3020270, G3020271, G3020276, G3020282, G3020283, G3020284, G3020285, G3020286, G3020287, G3020288, G3020289, G3020290, G3020291, G3020292, G3020293, G3020294, G3042776, G3054934, G3054935, G3056539, G3056540, G3056541, G3056542, G3056543, G3056544, G3056545, G3056546, G3056547, G3056548, G3056549, G3056550, G3056551, G3056552, G3056555, G3072337, G3072338, G3072339, G3072340, G3072341, G3072364, G3073380, G3079843
Recalling Firm/
Manufacturer		 Hitachi Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact SAME
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		 The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action Hitachi issued Urgent Medical Device Correction Letter to customers on 6/30/2021 using FedEx (with tracking). Letter states reason for recall, health risk and action to take: Customers/Users are advised to: 1. Remember to thoroughly inspect the probe before and upon completion of your cleaning and sterilization process and before and after any interoperative procedure as indicated in the Cleaning, Disinfection and Sterilization Instruction Manual including verifying the 2 screw covers are not loose, damaged, dislodged, or missing. 2. If any abnormalities exist, immediately remove the probe from service and contact Hitachi Customer Service at 1-800-800-4925. 3. Please complete the attached Medical Device Recall Return Response Form and return to Hitachi at your earliest convenience. Type of Action by the Company: An updated manual is included with newly manufactured L43K probes to include the above diagram for additional clarification. (7) Other Information: For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email piercea@hitachihealthcare.com
Quantity in Commerce 120 units
Distribution Worldwide distribution - US Nationwide and the country of Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = Hitachi Healthcare Americas
510(K)s with Product Code = IYN and Original Applicant = Hitachi Healthcare Americas Corporation
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