Recall Z-1686-2024 ยท ELC Scaler, Ultrasonic
Electro Medical Systems SA
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
| Date | Apr 24, 2024 (initiated Mar 13, 2024) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | 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 distributo |
| Quantity | 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, KAZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One E.M.S Electro Medical Systems S.A, Oct 20, 2019 |