Z-1514-2022 Class II Ongoing
FDA device recall Z-1514-2022 was initiated by Olympus Corporation Of The Americas on Jul 7, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 17, 2022
- Initiation Date
- Jul 7, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1514-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026