CLASS II ONGOING Device recall · Reported 17 Aug 2022 · FDA Enforcement Report

ShockPulse-SE Lithotripsy Generator recalled

Olympus Corporation of the Americas is recalling ShockPulse-SE Lithotripsy Generator, distributed nationwide in the US. The recall was initiated on 7 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1514-2022
FDA event ID: 90585
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jul 2022
FDA classified: 11 Aug 2022
Reported: 17 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Jul 2022	Recall initiated by company
11 Aug 2022	Classified by FDA	+35 days
17 Aug 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of AL, NM.

Nationwide Alabama New Mexico

Questions about this recall

Is ShockPulse-SE Lithotripsy Generator recalled?

Yes. Olympus Corporation of the Americas recalled ShockPulse-SE Lithotripsy Generator on 7 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-1514-2022.

Why was it recalled?

Which lots are affected?

UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Where was it sold?

US Nationwide distribution in the states of AL, NM.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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