| Class 2 Device Recall SOLTIVE SuperPulsed Laser System |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEX
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