FDA Device recall Z-1514-2022
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
- FDA Device
- Class II
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S by Olympus, citing 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 electrom….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1514-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-07 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
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
Identifiers
| code_info | UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1514-2022%22
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