Device product
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Z-2076-2019
Product summary
- Event
- Event 83310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 US
- Official record key
device-enforcement:Z-2076-2019
Official wording
Reason: Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
Code information: Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414
Distribution pattern: US distribution in AZ, and PA.
Derived failure modes
-
Unknown
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard