The FDA has classified a Class II recall for the Olympus ShockPulse-SE Lithotripsy System (Model SPL-S) due to a defect where the generator may remain in a blinking phase, indicating it is waiting to recognize the transducer. This issue can lead to damage to the transducer plug and/or generator receptacle. The recall is ongoing and affects worldwide distribution, including the US.

Medical device manufacturers and healthcare providers involved with this system should review the recall notice and take appropriate action. While specific compliance actions are not detailed in this notice, entities distributing or using this device should be aware of the potential for damage and the ongoing recall status. The FDA classifies this as a Class II recall, indicating that use of or exposure to a defective product may cause adverse health consequences that are temporary or medically reversible.