ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Check against the official notice below — it lists the full affected range.
Olympus Corporation of the Americas is recalling 2 units of the ShockPulse-SE Lithotripsy Generator Model SPL-S due to a mis-wired component. The improperly wired component can result in additional noise on the power supply output, which creates noise on the ultrasonic input circuit that does not meet electromagnetic compatibility standards. This issue may decrease the overall reliability of the system and result in delays to patient treatment.
The recalled units were distributed nationwide in Alabama and New Mexico. The affected units have serial numbers CG5085 and CG6009, with UDI-DI 00821925044197. The source document does not specify what remedy consumers should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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. Quantity: 2 units Lot/code info: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.