Device product
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
Z-1995-2014
Product summary
- Firm
- Cenorin, LLC
- Event
- Event 68580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 HLD systems
- Official record key
device-enforcement:Z-1995-2014
Official wording
Reason: 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 pasteurization cycle rather than using hot water.
Code information: 610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.
Distribution pattern: Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
Derived failure modes
-
Unknown
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 pasteurization cycle rather than using hot water.