| Class 2 Device Recall UST22652 Probe | |
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 | K134016 K142368 K162583 |
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 510(K)s with Product Code = ITX 510(K)s with Product Code = ITX
|
|
|
|