Olympus lithotripsy systems recalled over mis-wired component causing electrical noise

Plain-English summary

Olympus Corporation of the Americas is recalling the ShockPulse-SE Lithotripsy System Reusable Probes, model SPL-SR, containing generator SPL-G. The system uses pneumatically-created ballistic shock waves and ultrasonic waves for intracorporeal fragmentation of stones in the urinary tract. About 55 units, all outside the United States, were distributed to Canada, Germany, Singapore, Australia and India. The FDA has classified this recall as Class II.

An improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility standards and may decrease the overall reliability of the system and result in delay of treatment. Olympus discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component, and is expanding the action to those devices.

Affected product carries UDI 00821925043824 for SPL-SR and 00821925044203 for SPL-G, across 55 listed serial numbers beginning CG5026.

Facilities can identify affected systems by the model numbers, UDIs and serial numbers above, and may contact Olympus Corporation of the Americas for further information.

The recalled product

Product

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually

Manufacturer

Olympus Corporation of the Americas

Category

Medical Device — Lithotripsy

Hazard

• wiring-defect
• emc-noncompliance
• treatment-delay
• recall-expansion

Affected units

55

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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