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U.S. Department of Health and Human Services

Class 2 Device Recall Powered Laser Surgical Instrument

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 Class 2 Device Recall Powered Laser Surgical Instrumentsee related information
Date Initiated by FirmMay 06, 2025
Date PostedJune 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1923-2025
Recall Event ID 96723
510(K)NumberK242191 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductBrand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FBX200R-JA (Japan Only), TFL-FBX550R-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.
Code Information Lot Code: All lot numbers for the following models: Model UDI: 5 Pack / 1 Piece: TFL-FBX150R UDI: 00821925043893 / 00821925043909 TFL-FBX200R UDI: 00821925043954 / 00821925043961 TFL-FBX365R UDI: 00821925044012 / 00821925044029 TFL-FBX550R UDI: 00821925044050 / 00821925044067 TFL-FBX940R UDI: 00821925044104 / 00821925044098 TFL-FBX940R-JA (Japan Only); TFL-FBX365R-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150R-JA (Japan Only); TFL-FBX200R-JA (Japan Only); TFL-FBX550R-JA (Japan Only);
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
484-896-5000
Manufacturer Reason
for Recall		Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn May 6, 2025 URGENT: MEDICAL DECIVE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this letter, including Appendix 1 detailing the relevant Instructions for Use sections. 2. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of this letter, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers Instructions for Use. Include a copy of this letter with the Instructions for Use. You may continue to use the device as per this letter and the Instructions for Use. 3. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0470 c. Complete the form as instructed. 4. If you have further distributed this product, identify and forward them this letter. Olympus requests you to report any complaints, including fiber damage/breaks, smoke, sparks, flare, burning of a device or equipment, unsteady flames, steady flames and burns to a clinician or supporting staff occurring while using the SOLTIVE Laser Systems and SOLTIVE Laser Fibers. Olympus requests that you send the involved fiber(s) to Olympus for complaint investigation purposes. Please report complaints to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. 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. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
Quantity in Commerce2,675 units (190 US, 2485 OUS)
DistributionWorldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEX
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