Reported Aug 17, 2022 · Ongoing
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- ShockPulse-SE
- Lithotripsy Generator Model/SerialSPL-S
- Lot codes and dates
- UDI-DI00821925044197
- Serial numbersCG5085 and CG6009
- Amount recalled
- 2 units
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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