—#194859

Product

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

FDA product code: FEO — Lithotriptor, Ultrasonic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171024
Affected lot / code info: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, NM.

Timeline

Recall initiated: 2022-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194859. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.