# FDA recall Z-1514-2022

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2022-07-07.

## 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

## Distribution

US Nationwide distribution in the states of AL, NM.

## Key facts

- **Recall number:** Z-1514-2022
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-07
- **Report date:** 2022-08-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1514-2022

## Citation

> AI Analytics. FDA recall Z-1514-2022. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1514-2022. Source: US FDA. Licensed CC0.

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