Olympus Corporation of the Americas is recalling 3,368 units of the ShockPulse-SE Lithotripsy System, including generators and both reusable and single-use probes. Ongoing investigations found that the device generator can get stuck in a 'blinking phase' and fail to recognize the connected transducer, often caused by physical damage to the plug or receptacle. This system is used in medical procedures to break up kidney and bladder stones. Patients and providers should be aware that this failure could delay or interrupt surgical procedures. You should contact Olympus or your distributor to arrange for a return, replacement, or correction of the device.
Damage to the transducer plug or generator receptacle can prevent the system from recognizing the transducer, causing the generator to remain in a blinking standby state. This failure can lead to surgical delays or the inability to complete the stone fragmentation procedure as intended.
Recall #: Z-1477-2026; Quantity: 602 units
Recall #: Z-1478-2026; Quantity: 1082 units
Recall #: Z-1479-2026; Quantity: 1684 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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