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HYDRIM C61W G4 Instrument Washer
Dent4You AG · Model C61W-D01-R · UDI-DI 07640397421908
10
510(k) clearances
95
Adverse events
11
Recalls
11
Facilities
Description
Automated instrument washer (Refurbished)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-09 | Cenorin, LLC | There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn. |
| 2016-04-22 | Natus Medical Incorporated | The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during |
| 2014-04-24 | Cenorin, LLC | Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid dur |
| 2013-01-24 | Cenorin, LLC | The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pa |
| 2010-06-07 | Cenorin | The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it pr |
| 2010-06-07 | Cenorin | The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false |
| 2010-06-07 | Cenorin | The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it pr |
| 2010-06-07 | Cenorin | The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it pr |
| 2006-12-21 | Cenorin | Potential for user to receive an electrical shock. |
| 2006-12-21 | Cenorin | Potential for user to receive an electrical shock. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.