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U.S. Department of Health and Human Services

Class 2 Device Recall UST22652 Probe

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  Class 2 Device Recall UST22652 Probe see related information
Date Initiated by Firm January 31, 2020
Create Date February 20, 2020
Recall Status1 Terminated 3 on July 31, 2020
Recall Number Z-1341-2020
Recall Event ID 84838
510(K)Number K162583  K142368  K134016  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
Code Information Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Aaron J. Pierce
330-425-1313 Ext. 2934
Manufacturer Reason
for Recall		 These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
FDA Determined
Cause 2		 Process change control
Action On January 31, 2020, the firm initiated customer communications via Urgent Medical Device Recall letters. Customers were informed of the potential mis-wiring issue. Clinicians are advised to discontinue use of the probes to minimize adverse events. Hitachi Service will contact each affected site to schedule a service visit. Hitachi will test all affected probes and remove and replace any probes that do not pass the test. The correction is expected to begin February 2020.
Quantity in Commerce 18
Distribution Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to 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 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, LTD.
510(K)s with Product Code = ITX and Original Applicant = HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL
510(K)s with Product Code = ITX and Original Applicant = HITACHI, LTD.
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