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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 FirmAugust 13, 2024
Date PostedOctober 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0134-2025
Recall Event ID 95380
510(K)NumberK221306 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductSoltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Code Information UDI 00821925044111 All Serial Numbers:
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		The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus issued Urgent Medical Device Correction Letter on 9/12/24 to Operating Room Director, Risk Management. Letter states reason foe recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Please check all areas of your facility to determine if you have the devices specified above. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use. 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. 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: "0452 c. Complete the form as instructed. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@Olympus.com or by phone at (647) 999-3203
Quantity in Commerce1373 units
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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