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FDAJuly 7, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925044197

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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