Z-1514-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2022
- Initiation Date
- July 7, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of AL, NM.
Code Information
UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009