FDA recall Z-1514-2022

Olympus Corporation of the Americas · Class II · device

Product

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

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

Distribution

US Nationwide distribution in the states of AL, NM.

Key facts

Status: Ongoing
Initiation date: 2022-07-07
Report date: 2022-08-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1514-2022