Olympus Corporation of the Americas: Medical Device Recall in 2022 - (Recall #: Z-1514-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Product Classification:

Class II

Date Initiated: July 7, 2022

Date Posted: August 17, 2022

Recall Number: Z-1514-2022

Event ID: 90585

Reason for Recall:

Mis-wired component-the 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 (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009

Distribution Pattern:

US Nationwide distribution in the states of AL, NM.

Voluntary or Mandated:

Voluntary: Firm initiated