Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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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 stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.. Reason: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.. Classification: Class II. Quantity: 602 units. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
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Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
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Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Defective container; inadequately sealed blister packaging.