ShockPulse-SE Lithotripsy Generator recall
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Why was ShockPulse-SE Lithotripsy Generator 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
- Product
- ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of AL, NM.
- Recall date
- August 17, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)