Lithotripsy transducers recalled over startup failures and handpiece temperature rise
Olympus is recalling 1,528 ShockPulse Lithotripsy Transducers because the device may fail to start or stop shortly after starting, and the handpiece body may heat up during clinical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: a device that stops mid-procedure and a handpiece that heats during use are hazards, and no injuries are reported.
Plain-English summary
The ShockPulse Lithotripsy Transducer, model SPL-T, from Olympus, is being recalled. The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone fragments.
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
The recall covers 1,528 units across all serial numbers, carrying UDI-PI 00855279005023, distributed worldwide including nationwide in the United States and to Canada, India, Taiwan, Germany, Australia and Singapore. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities operating an affected transducer should follow Olympus' instructions.
The recalled product
- Product
- Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,528
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-T
- UDI-PI: 00855279005023
- All serial numbers
Distribution
Distributed nationwide across the United States.
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