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HomeScican Ltd › HYDRIM L110W Instrument Washer

HYDRIM L110W Instrument Washer

Scican Ltd · Model L110W-D01-L · UDI-DI 07540196001007

LDS
10
510(k) clearances
95
Adverse events
11
Recalls
11
Facilities

Description

Automated instrument washer (Loaner)

Recalls

DateFirmReason
2018-04-09Cenorin, LLCThere is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
2016-04-22Natus Medical IncorporatedThe 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
2014-04-24Cenorin, LLCCenorin 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
2013-01-24Cenorin, LLCThe 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
2010-06-07CenorinThe 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
2010-06-07CenorinThe 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
2010-06-07CenorinThe 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
2010-06-07CenorinThe 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
2006-12-21CenorinPotential for user to receive an electrical shock.
2006-12-21CenorinPotential for user to receive an electrical shock.

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Data 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.