Olympus ShockPulse-SE Lithotripsy System Generator Connector Malfunction Recall
Olympus is recalling 602 ShockPulse-SE Lithotripsy Systems due to generator malfunction caused by connector damage. The generator may fail to recognize the transducer, preventing proper device operation during stone fragmentation procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm medical device where malfunction could prevent proper patient treatment. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Olympus Corporation of the Americas is recalling 602 units of the ShockPulse-SE Lithotripsy System (Model SPL-SR). This is a Class II recall. The device is an electromechanical system used to fragment kidney stones using mechanical shock waves and ultrasonic energy.
Ongoing investigations have identified instances where the device generator becomes stuck in a blinking phase and fails to recognize the transducer probe. Damage to the transducer plug connector and/or the generator receptacle can cause this malfunction. When these connectors are damaged, the device cannot function properly.
The affected units have been distributed worldwide, including throughout the United States and in Canada, Mexico, Bolivia, Chile, India, China, the European Union, Singapore, Australia, Korea, and Japan.
Healthcare providers should contact Olympus Corporation of the Americas for guidance regarding the recall and any affected units.
The recalled product
- Product
- Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Hazard
- device-malfunction
- connection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: SPL-SR
- UDI: 00821925043824
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
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