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U.S. Department of Health and Human Services

Class 2 Device Recall PIEZON Bottle

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  Class 2 Device Recall PIEZON Bottle see related information
Date Initiated by Firm March 13, 2024
Date Posted April 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-1688-2024
Recall Event ID 94293
510(K)Number K190124  
Product Classification Scaler, ultrasonic - Product Code ELC
Product Brand Name: PIEZON Bottle
Product Name: PIEZON Bottle
Model/Catalog Number: EG-111
Software Version: N/A
Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use.
Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
Code Information Lot Code: Model number: EG-111, UDI: 07613353180249 Lot number: 16442-190, Expiry date: 2026-04 Model number: EG-111, UDI: 07613353180249 Lot number: 16694-30 Expiry date: 2026-07 AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: KU23667 KU23689 KU23700 KU23701 KU23703 KU23722 KU24328 KU24330 KU24331 KU24333 KU24334 KU24335 KU24337 KU24339 KU24340 KU24341 KU23719 KU24336 KU24338 KU24342 KU24344 KU24346 KU24349 KU24354 KU24356 KU23666 KU23672 KU23678 KU23686 KU23688 KU23706 KU23716 KU24343 KU24345 KU24347 KU24348 KU24350 KU24351 KU24353 KU24355 KU24357 KU24363 KU24366 KU24367 KU24368 KU24369 KU24370 KU24371 KU24372 KU24373 KU24359 KU24360 KU24361 KU24365
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 54
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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