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U.S. Department of Health and Human Services

Class 2 Device Recall Verathon BladderScan Prime Plus Probe

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  Class 2 Device Recall Verathon BladderScan Prime Plus Probe see related information
Date Initiated by Firm September 29, 2020
Create Date December 03, 2020
Recall Status1 Terminated 3 on June 29, 2022
Recall Number Z-0531-2021
Recall Event ID 86528
510(K)Number K172356  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Code Information Part Number: 0570-0395 Device Listing Number: D318438 UDI Code: 0 0879123 00649 3 Serial Numbers: P1001848 P1500333 P1500436 P1500486 P1500517 P1500519 P1500528 P1500604 P1500642 P1500657 P1501000 P1501088 P1501102 P1501115 P1501122 P1501247 P1501255 P1501259 P1501326 P1501330 P1501394 P1501399 P1501607 P1501625 P1501739 P1501765 P1501779 P1501788 P1501845 P1501911 P1501979 P1502058 P1503069 P1503070 P1503071 P1503072 P1503073 P1503074 P1503075 P1503076 P1503077 P1503078 P1503079 P1503080 P1503081 P1503082 P1503083 P1503084 P1503085 P1503086 P1503087 P1503088 P1503089 P1503093 P1503096 P1503098 P1503099 P1503100 P1503102 P1503104 P1503106 P1503109 P1503110 P1503111 P1503112 P1503113 P1503114 P1503117 P1503118 P1504415 P1504427 P1504463 P1504564 P1504664 P1504754 P1504906 P1505005 P1505019 P1505119 P1505133 P1505181 P1505208 P1505479 P1505481 P1505491 P1505496 P1505506 P1505531 P1505676 P1505695 P1505696 P1505762 P1505782 P1505788 P1505845 P1505874 P1505951 P1506018 P1506066 P1506161 P1506253 P1506309 P1506332 P1506348 P1506351 P1506356 P1506363 P1506371 P1506401 P1506546 P1506558 P1506737 P1506807 P1506904 P1506921 P1507029 P1507084 P1507091 P1507124 P1507202 P1507221 P1507391 P1507412 P1507652 P1507728 P1507801 P1507980 P1507987 P1508116 P1508123 P1508181 P1508202 P1508279 P1508375 P1508386 P1508495 P1508536 P1508597 P1508646 P1508738 P1508739 P1508780 P1508818 P1509049 P1509052 P1509317 P1509325 P1509339 P1509417 P1509444 P1509487 P1509530 P1511230 P1511755 P1517688 P1517690 P1517691 P1517692 P1517693 P1517694 P1517695 P1517696 P1517697 P1517698 P1517699 P1517700 P1517701 P1517702 P1517703 P1517709 P1517710 P1517711 P1517712 P1517713 P1517714 P1517715 P1517716 P1517731 P1517732 P1517733 P1517734 P1517736 P1517737 P1517738 P1517739 P1517740 P1517741 P1517742 P1517743 P1517744 P1517745 P1517746 P1517747 P1517748 P1517749 P1517750 P1517751 P1517752 P1517753 P1517754 P1517755 P1517756 P1517757 P1517758 P1517759 P1517760 P1517761 P1517762 P1517763 P1517764 P1517765 P1517766 P1517767 P1517768 P1517771 P1517773 P1517774 P1517775 P1517776 P1517777 P1517778 P1517779 P1517780 P1517781 P1517782 P1517783 P1517785 P1517829 P1517835 P1517837 P1517838 P1517839 P1517840 P1517841 P1517842 P1517843 P1517844 P1517845 P1517846 P1517873 P1517874 P1517876 P1517878 P1517879 P1517880 P1517884 P1517885 P1517889 P1517890 P1517891 P1517892 P1517893 P1517894 P1517895 P1517896 P1517897 P1517898 P1517900 P1517901 P1517907 P1517908 P1517909 P1517910 P1517911 P1517912 P1517913 P1517914 P1517915 P1517916 P1517917 P1517918 P1517919 P1517920 
Recalling Firm/
Manufacturer		 Verathon, Inc.
20001 N Creek Pkwy
Bothell WA 98011-8218
For Additional Information Contact Laura Hoffman
425-375-3431
Manufacturer Reason
for Recall		 Due to a change in handle material and process, probe handle may crack.
FDA Determined
Cause 2		 Vendor change control
Action On 10/5/2020, the firm sent a "Field Defect Correction URGENT MEDICAL DEVICE RECALL" Notification to its U.S, Customers via FedEx informing them that due to an unauthorized manufacturing change, the probe handle's plastic may become brittle and crack. Customer are instructed to: 1. Review the information contained within this Recall Notice with all staff members who should be aware of the contents of the letter. 2. Check the list of Serial Numbers that are provided within the Recall Response Form. 3. Perform a visual inspection of the probe handle for cracks or damage. 4. Based on the visual inspection of your device(s), please do one of the following: a. Unboxing and Initial Use " If your BladderScan Prime Plus probe handle plastics have no visible cracks or damage and / or you do not wish for units to be serviced, complete the attached Recall Response Form by indicating no or 0 in the text box and return the form to Verathon by email to CSNotifications@verathon.com. Or " If your BladderScan Prime Plus probe handle plastics have visible cracks and you wish for these units to be serviced, complete attached Recall Response Form by indicating by number the count of probe handle plastics that require repair in the text box and return the form by email to CSNotifications@verathon.com. Verathon Customer Care will contact you to arrange for repair of the probe handle plastics. This replacement will be at no charge to you. b. Subsequent Use If subsequent to submitting your Recall Response Form your BladderScan Prime Plus probes develop cracks (reference Figure 1) during subsequent use and you wish for them to be serviced, please email CSNotifications@verathon.com. Verathon Customer Care will contact you to arrange for repair of the probe handle plastics. This replacement will be at no charge to you. Follow the instructions within the BladderScan Prime Plus Operations and Maintenance Manual (0900-4510 Rev. 11), and as stated below, for conduct
Quantity in Commerce 398 units
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY. The countries of Austrailia, Belgium, Canada, France, Germany, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and United Kingdom.
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 = Verathon Incorporated
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