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U.S. Department of Health and Human Services

Class 2 Device Recall SOLTIVE SuperPulsed Laser System

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  Class 2 Device Recall SOLTIVE SuperPulsed Laser System see related information
Date Initiated by Firm January 29, 2024
Date Posted March 27, 2024
Recall Status1 Open3, Classified
Recall Number Z-1384-2024
Recall Event ID 94125
510(K)Number K221306  
Product Classification Powered laser surgical instrument - Product Code GEX
Product SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Code Information Model Number: TFL-SLS; UDI/DI: 00821925044135; All serial numbers.
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
FDA Determined
Cause 2		 Under Investigation by firm
Action On February 21, 2024, the firm notified customers of the issue via MEDICAL DEVICE CORRECTION letters. Actions to be taken by the customer: 1. Ensure all personnel, including clinical staff, are completely knowledgeable and thoroughly aware of the contents of this letter. 2. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 3. Confirm that the installed power cord meets the specifications detailed in this letter via your Biomedical Department or other appropriate personnel. You may continue using your Soltive Laser System after confirming the specifications of the power cord. 4. If you have questions regarding the specifications of the power cord, are unable to confirm the specifications, or if you identify that the cord does not meet the specifications, quarantine your Soltive Laser System and contact your local Olympus representative to receive additional guidance and/or to schedule an immediate on-site inspection. 5. Olympus Service will reach out to you to schedule an on-site service to inspect the power cord. If the power cord is found to be non-compliant, it will be replaced at no cost to you. Olympus requests you to report any complaints, including any injuries associated with the Soltive Laser, to your Regional Complaint Intake Contact. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the regional contact for Olympus provided in the letter.
Quantity in Commerce 17 Units (OUS Only)
Distribution Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = Gyrus ACMI, Inc.
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