Castellini
CEFLA SOCIETA' COOPERATIVA · Model DAMA AMBIDX · UDI-DI 08033837933939
Description
The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental handpieces, multifunction pedal. In this version, the hydric unit and the dentist board are not present. The device consists of the single dental chair and, optionally, of the assistant's board with instruments connected to it. The patient dental chair can mount single-phase lifting motors (catalog number: 72CCXXXX) or three-phase lifting motors (catalog number: 72CDXXXX). The last four characters "XXXX" of the catalog number can be different alphanumeric characters.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-30 | Dental EZ Group Star Dental Division | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury |
| 2024-05-30 | Dental EZ Group Star Dental Division | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury |
| 2024-03-13 | Electro Medical Systems SA | 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 |
| 2024-03-13 | Electro Medical Systems SA | 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 |
| 2024-03-13 | Electro Medical Systems SA | 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 |
| 2022-10-14 | Sonendo Inc | Procedure Instruments with erroneous unit carton labels. |
| 2022-10-14 | Sonendo Inc | Procedure Instruments with erroneous unit carton labels. |
| 2019-10-23 | Sonendo Inc | The console would continue to run for extended period when the foot pedal was released. |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that |
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