High FDA (Devices)·Z-1514-2022·Announced 2022-08-17

Lithotripsy Generator Recall Due to Mis-Wired Component Affecting System Reliability

Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.

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 is a Class II FDA device recall where the mis-wired component creates an EMC non-compliance that impairs device functionality. Although no injuries have been reported, the potential for device unreliability and treatment delay in a critical medical application constitutes a risk-of-harm product situation.

Plain-English summary

Olympus Corporation of the Americas is recalling 2 units of the ShockPulse-SE Lithotripsy Generator (Model/Serial SPL-S). The affected units are identified by serial numbers CG5085 and CG6009 (UDI-DI: 00821925044197).

The reason for the recall is a mis-wired component on the device. This component can result in additional noise on the power supply output. The noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards, which may decrease the overall reliability of the system and result in delayed treatment.

The affected units were distributed nationwide in Alabama and New Mexico.

The recalled product

Product: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Equipment / Lithotripsy
Hazard: electrical-noise
emc-non-compliance
system-unreliability
Affected units: 2

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 (1)

UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · electrical noise