ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Reported: August 17, 2022 Initiated: July 7, 2022 #Z-1514-2022
Product Description
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
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 2 units
- Distribution
- US Nationwide distribution in the states of AL, NM.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S. Recalled by Olympus Corporation of the Americas. Units affected: 2 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2022. Severity: Moderate. Recall number: Z-1514-2022.
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