Device product
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
Z-2288-2018
Product summary
- Firm
- Cenorin, LLC
- Event
- Event 80295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-2288-2018
Official wording
Reason: There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
Code information: Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610
Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan
Derived failure modes
-
Unknown
There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.