SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
This recall is currently active, issued March 27, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- January 29, 2024
- Posted
- March 27, 2024
- Recall Number
- Z-1384-2024
- Quantity
- 17 Units (OUS Only)
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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.
Distribution
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Lot / Code Info
Model Number: TFL-SLS; UDI/DI: 00821925044135; All serial numbers.
Root Cause
Under Investigation by firm
Action Taken
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.