ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S — Class II medical device recall Z-1514-2022
Ongoing recall by Olympus Corporation of the Americas, reported 2022-08-17, distributed nationwide. Mis-wired component-the improperly wired component can result in additional noise on the power supply output.
| Recall number | Z-1514-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2022-07-07 |
| Classified | 2022-08-11 |
| Reported by FDA | 2022-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 00821925044197 |
| Serial numbers | CG5085, CG6009 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1514-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.