SHOCKPULSE recallZ-1514-2022 · Olympus Corporation of the Americas · initiated Jul 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-1514-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 7, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 2 units
- Product code
- FEO
- FDA submissions
- K171024
- Distribution
- US Nationwide distribution in the states of AL, NM.
Product description
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Code information (models, lots, serial numbers)
UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ShockPulse SPL-SGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls159 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K171024 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ShockPulse SPL-TGyrus ACMI, LLC · Lithotriptor, ultrasonic279 reports
- ShockPulse SPL-GGyrus ACMI, LLC · Lithotriptor, ultrasonic2 recalls10 reports
- ShockPulse SPL-FSGyrus ACMI, LLC · Lithotriptor, ultrasonic20 reports
- SHOCKPULSE SPL-PDBX150Gyrus ACMI, LLC · Lithotriptor, Ultrasonic2 reports
- Gyrus ACMI SPL-WGyrus ACMI, LLC · Lithotriptor, ultrasonic1 report
- SHOCKPULSE SPL-PDBX183Gyrus ACMI, LLC · Lithotriptor, Ultrasonic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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