ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Summary
The FDA issued a Class II for ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S by Olympus Corporation of the Americas. Reason: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is.
Details
Source
Device Recall
External ID
Z-1514-2022
Action Date
2022-08-17
Status
Ongoing
Category
device
Product Description
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Lot/Code Info: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
Quantity Affected: 2 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-07
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1514-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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