Device product
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Z-1514-2022
Product summary
- Event
- Event 90585
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1514-2022
Official wording
Reason: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
Code information: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
Distribution pattern: US Nationwide distribution in the states of AL, NM.
Derived failure modes
-
Unknown
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment