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Steelco
STEELCO SPA · Model DS 500 CDL · UDI-DI 08058341876558
2
510(k) clearances
1,315
Adverse events
31
Recalls
40
Facilities
Description
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-19 | Steris Corporation | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of s |
| 2025-11-19 | Steris Corporation | Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of s |
| 2025-08-29 | Getinge Disinfection Ab | Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not tri |
| 2025-04-02 | Getinge Disinfection Ab | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and t |
| 2025-04-02 | Getinge Disinfection Ab | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and t |
| 2023-04-10 | Steris Corporation | In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heatin |
| 2022-04-22 | Steris Corporation | The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could over |
| 2022-04-13 | Getinge Usa Sales Inc | Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury |
| 2022-04-13 | Getinge Usa Sales Inc | Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury |
| 2022-04-01 | Getinge Usa Sales Inc | Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and |
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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.