ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
FDA Recall Z-1514-2022 · Posted None
Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeFEO
Date Initiated2022-07-07
Product Quantity2 units
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
Firm Action
Olympus issued Urgent Medical Device Recall Letter dated July 7, 2022. Letter states reason for recall, health risk and action to take:
1. Immediately locate the generator with the serial numbers listed in this communication. The serial number is located on the back of the unit.
2. Your sales representative will work with you to arrange for the return of your unit and assist with initiating an order for a replacement unit.
3. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. Go to https://olympusamerica.com/recall. Enter the recall number 0410 and provide your contact information as indicated in the portal.
4. If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Contact (647) 999-3203 or at [email protected] for any additional information or support concerning this matter.
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution in the states of AL, NM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.