Recall Z-1514-2022 ยท FEO Lithotriptor, Ultrasonic
Olympus Corporation of the Americas
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
| Date | Jul 7, 2022 |
| Status | Open, Classified |
| 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 |
| Root 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 041 |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of AL, NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171024 | ShockPulse-SE Lithotripsy System Cybersonics, Inc., Aug 21, 2017 |