Olympus lithotripsy generator recalled over transducer recognition failure
Olympus is recalling the ShockPulse-SE Lithotripsy System Generator after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the generator can fail to recognise its transducer and become unusable during a procedure, and no injuries are stated in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling the ShockPulse-SE Lithotripsy System Generator, model SPL-G. The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. About 1,684 units were distributed worldwide, covering the United States nationwide and Canada, Mexico, Bolivia, Chile, India, China, the EU, Singapore, Australia, Korea and Japan. The FDA has classified this recall as Class II.
Ongoing investigations identified additional instances of the device generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug or generator receptacle may cause these issues.
All serial numbers are affected. The device carries UDI 00821925044203.
Facilities can identify affected generators by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Lithotripsy
- Affected units
- 1,684
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-G
- UDI: 00821925044203
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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