Olympus Corporation of the Americas Recall 90585
Description: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Olympus Corporation of the Americas Recall 90585 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1514-2022 |
| Event ID | 90585 |
| Event Description | ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, NM. |
| Quantity | 2 units |
| Recall 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 |
| Device Classification | 20220817 |
| Device Code Info | UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009 |
| Center Classification Date | 20220811 |
| Recall Initiation Date | 20220707 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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