FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
- Recall number
- Z-1514-2022
- Recalling firm
- Olympus Corporation of the Americas
- Product
- ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
- Status
- Open, Classified
- Initiated
- 2022-07-07
- Posted
- not on file
- Terminated
- not on file
- 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 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
- 2 units
- Distribution
- US Nationwide distribution in the states of AL, NM.
- Lot, serial or model codes
- UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
- 510(k) numbers
- ["K171024"]
- PMA numbers
- not on file
- Product code
- FEO
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28