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U.S. Department of Health and Human Services

Class 2 Device Recall SOLTIVE SuperPulsed Laser Fibers

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 Class 2 Device Recall SOLTIVE SuperPulsed Laser Fiberssee related information
Date Initiated by FirmDecember 04, 2023
Date PostedJanuary 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0718-2024
Recall Event ID 93629
510(K)NumberK221306 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductSOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Code Information UDI-DI 00821925043985 Lot KR262848
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-999-3203
Manufacturer Reason
for Recall		Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.
Quantity in Commerce179 units
DistributionDomestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
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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