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U.S. Department of Health and Human Services

Class 2 Device Recall CLEANER BOTTLE

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  Class 2 Device Recall CLEANER BOTTLE see related information
Date Initiated by Firm March 13, 2024
Date Posted April 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-1686-2024
Recall Event ID 94293
510(K)Number K190124  
Product Classification Scaler, ultrasonic - Product Code ELC
Product Brand Name: CLEANER BOTTLE
Product Name: CLEANER BOTTLE
Model/Catalog Number: EG-1000
Software Version: N/A
Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning.
Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
Code Information Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: KU23665 KU23668 KU23669 KU23670 KU23671 KU23673 KU23674 KU23675 KU23676 KU23677 KU23679 KU23680 KU23681 KU23682 KU23683 KU23684 KU23685 KU23687 KU23690 KU23691 KU23692 KU23693 KU23694 KU23695 KU23696 KU23697 KU23698 KU23699 KU23702 KU23704 KU23705 KU23707 KU23708 KU23709 KU23710 KU23711 KU23712 KU23713 KU23714 KU23715 KU23717 KU23718 KU23720 KU23721 KU23723 KU23724 LD05012 LD05033 LD05034 LD05035 LD05036 LD05037 LD05100 LD05101 LD05102 LD05103 LD05104 LD05105 LD05106 LD05107 LD05108 LD05109 LD05110 LD05111 LD05112 LD05113 LD05114 LD05115 KU23666 KU23667 KU23672 KU23678 KU23686 KU23688 KU23689 KU23700 KU23701 KU23703 KU23706 KU23722 KU24328 KU24341 KU23716 KU23719 KU24342 KU24343 KU24344 KU24345 KU24346 KU24347 KU24348 KU24349 KU24350 KU24351 LD05116 LD05117 LD05118 LD05119 LD05120 LD05121 LD05122 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 KU21778 KU21884 KU21915 KU21948 KU21972 KU22135 KU22136 KU22137 KU22138 KU22139 KU22140 KU22141 KU22142 KU22143 KU22146 KU22147 KU22165 KU22166 KU22167 KU22168 KU22169 KU22170 KU22171 KU22172 KU22173 KU22174 KU22175 KU22176 KU22177 KU22178 LD05038 LD05039 LD05041 LD05042 KU21767 KU21990 KU21991 KU22592 KU23365 KU23366 KU23367 KU23368 KU23369 KU23370 KU23371 KU23372 KU23373 KU23374 KU23375 KU23376 KU23378 KU23379 KU23381 KU23382 LD05093 LD05536 LD05094 LD05095 LD05096 KU23023 KU23026 KU23027 KU23029 KU23030 KU23031 KU23032 KU23064 KU23112 KU23119 KU23120 KU23123 KU23128 KU23131 KU23132 KU23252 KU23263 KU23264 KU23265 KU23266 KU23267 KU23268 KU23269 KU23270 KU23271 KU23272 KU23273 KU23275 KU23276 KU23277 KU23278 KU23279 KU23280 KU23281 KU23282 KU23283 KU23284 KU23289 KU23294 KU23305 LD05537 LD05097 LD05098 LD05099 LD05538 LD05539 LD05540 LD05541 LD05542 KU25788 KU25789 KU25790 KU25791 KU25792 KU25793 KU25794 KU25795 KU25796 KU25797 KU25798 KU25799 KU25800 KU25801 KU25802 KU25803 LD05607 LD05664 LD05665 LD05666 LD05667 LD05668 LD05669 LD05670 LD05671 LD05672 LD05673 LD05674 LD05675 LD05676 LD05677 LD05678 KU25758 KU25759 KU25760 KU25761 KU25762 KU25763 KU25764 KU25765 KU25766 KU25767 KU25768 KU25769 KU25770 KU25771 KU25772 KU25773 LD05679 LD05680 LD05681 LD05682 LD05683 LD05684 LD05685 LD05686 LD05687 KU26136 KU26140 KU26141 KU26142 KU26143 KU26144 KU26145 KU26146 KU26155 KU26846 KU26968 KU26969 KU26970 KU26971 KU26972 KU26973 KU26974 KU26975 KU26976 KU26977 KU26978 KU26979 KU26980 KU26981 KU26091 KU26094 KU26097 KU26168 LD05723 LD05724 LD05725 LD05726 LD05727 KU26205 KU26206 KU26218 KU26219 KU26220 KU26221 KU26222 KU26223 KU26224 KU26225 KU26226 KU26227 KU26228 KU26229 KU26230 KU26231 KU26281 KU26284 KU26285 KU26289 EG-1000A x1 OF-99-12848-1
Recalling Firm/
Manufacturer		 Electro Medical Systems SA
Chemin De La Vuarpilliere 31
Nyon Switzerland
For Additional Information Contact Alfred Gonzales
972-6908382
Manufacturer Reason
for Recall		 Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
FDA Determined
Cause 2		 Process control
Action On 3/13/2024, the firm notified, via email, its distributors and asked them to extend the recall to end users. Currently the Customer Notification Letter to end users is being drafted (date of distribution pending). The Customer Notification Letter will information customers that the firm is recalling WATER, CLEANER and PIEZON Bottles due to a manufacturing issue that may result with these affected bottles to leak and/or break and in unfavorable cases may lead to injuries. Customers are instructed to: 1. Cease use of the affected products. 2. Return the affected products to their distributors For questions or assistance, contact EMS Dallas at 1-800-367-0367 or email to emsrepairs@ems-na.com Monday thru Friday 8:00 a.m. to 5:00 p.m. CST.
Quantity in Commerce 342
Distribution Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.
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 = ELC and Original Applicant = E.M.S Electro Medical Systems S.A.
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