Class 2 Device Recall ShockPulseSE Lithotripsy System

• Date Initiated by Firm: July 07, 2022
• Create Date: August 11, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1514-2022
• Recall Event ID: 90585
• 510(K)Number: K171024
• Product Classification: Lithotriptor, ultrasonic - Product Code FEO
• Product: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
• Code Information: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
• FEI Number: 2429304
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer 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
• FDA Determined Cause: Process change control
• 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 Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.
• Quantity in Commerce: 2 units
• Distribution: US Nationwide distribution in the states of AL, NM.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FEO